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 Table of Contents  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 10  |  Issue : 4  |  Page : 225-237

A multicenter, observational, homoeopathic clinical verification study of Cynodon dactylon revealing symptom prevalence in a cohort of 340 patients


1 Central Council for Research in Homoeopathy, New Delhi, India
2 Dr. Anjali Chatterjee Regional Research Institute (Homoeopathy), Kolkata, West Bengal, India
3 Dr. D.P. Rastogi, Central Research Institute (Homoeopathy), Noida, Uttar Pradesh, India
4 Regional Research Institute for Homoeopathy, Puri, Odisha, India
5 Retired, Regional Research Institute for Homoeopathy, Gudivada, Andhra Pradesh, India
6 Regional Research Institute for Homoeopathy, Imphal, Manipur, India
7 Retired, Dr. D.P. Rastogi Central Research Institute (Homoeopathy), Noida, Uttar Pradesh, India
8 Independent Researcher, Homoeopathy University, Jaipur, Rajasthan, India
9 President, Homoeopathy University, Jaipur, Rajasthan, India

Date of Web Publication17-Nov-2016

Correspondence Address:
Parthasarathi Chakraborty
Dr. Anjali Chatterjee Regional Research Institute (Homoeopathy), Under Central Council for Research in Homoeopathy, 50, Rajendra Chatterjee Road, Kolkata - 700 035, West Bengal
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-7168.194298

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  Abstract 

Context: Clinical verification is an ongoing research program of the Council that verified many rare homoeopathic drugs. Aim: This study was carried out to clinically verify the "symptomatology" of Cynodon dactylon and to ascertain the prevalence of symptoms in the "improved" and "not improved" groups. Materials and Methods: The study was a multicenter, open, observational study. A total of 462 patients were enrolled after matching with the available symptom, compendium of the drug, and eligibility criteria in seven units/institutes of the Council. The medicine was prescribed in 6C, 30C, 200C and 1M potencies as per the need of each patient, following homoeopathic principles and the protocol developed by the Council. The collected data were presented in terms of descriptive statistics. Prevalence of the symptoms in the responding and nonresponding population was compared using Chi-square test or Fisher's exact test, as appropriate. Results: A total of 340 complete cases were analyzed; male/female was 204/136; mean age was 29.7 years. There were "clinical successes" in 274 (80.6%) cases and "failures" in 66 (19.4%), judged subjectively by the physicians. A minimum of two prescriptions was considered for pick-listing each symptom as per protocol. The number of symptoms verified was as follows: proving symptoms (n = 43), symptoms from other literature (n = 10), and new clinical observations (n = 57). Conclusions: A total of 53 recorded symptoms were verified and 57 new clinical symptoms were identified. Further replication and estimation of likelihood ratio in general practice settings are crucial for confirmatory inclusion of the symptoms in homoeopathic literature.

Keywords: Clinical verification, Cynodon dactylon, Homoeopathy, Observational study


How to cite this article:
Manchanda R, Chakraborty P, Singh P, Pradhan P K, Prasad V G, Singh O, Rai M K, Koley M, Saha S, Nayak C. A multicenter, observational, homoeopathic clinical verification study of Cynodon dactylon revealing symptom prevalence in a cohort of 340 patients. Indian J Res Homoeopathy 2016;10:225-37

How to cite this URL:
Manchanda R, Chakraborty P, Singh P, Pradhan P K, Prasad V G, Singh O, Rai M K, Koley M, Saha S, Nayak C. A multicenter, observational, homoeopathic clinical verification study of Cynodon dactylon revealing symptom prevalence in a cohort of 340 patients. Indian J Res Homoeopathy [serial online] 2016 [cited 2017 Mar 27];10:225-37. Available from: http://www.ijrh.org/text.asp?2016/10/4/225/194298


  Introduction Top


In India, almost 95% of the prescriptions are plant-based in the traditional Ayurveda, Unani, Siddha and Homoeopathy systems. [1] Among the plants, Cynodon dactylon, a perennial grass of Poaceae family, native to the warm temperate and tropical regions, is an important one. [2] It is reported to have important properties such as anabolic, antiseptic, astringent, cyanogenetic, demulcent, depurative, laxative, diuretic and emollient. [3] It is used by traditional healers for purifying blood, anuria, biliousness, conjunctivitis, diarrhoea, gonorrhoea, itches and stomachache. [4] The plant is a rich source of β-sitosterols, flavonoids, alkaloids, glycosides and triterpenoids. [5] Some of the identified flavonoids are quercetin, kaempferol, catechin and myricetin. Of the carotenoids, β-carotene, lutein, violaxanthin and zeaxanthin are important. [6] Ethnopharmacobotanical studies investigating indigenous knowledge of medicinal plants among village people and tribal minorities reported Cynodon dactylon as one of the most frequently used medicinal plants. [7],[8],[9],[10],[11],[12],[13] The juice of the plant is astringent and is applied externally as first aid to fresh cuts and wounds. The plant is a folk remedy for catarrhal ophthalmia, hysteria, epilepsy, insanity, chronic diarrhoea, anasarca, calculus, carbuncles, cough, hypertension, snake bites, gout, and rheumatic affections. It is bitter and sharp hot in taste, has good odor, works as laxative, brain and heart tonic, aphrodisiac, expectorant, carminative, and is useful against grippe in children and for pains, inflammations, and toothache. [3] Numerous in-vivo and in-vitro activities and traditional uses have been noted; for example, anti-inflammatory, [14],[15] antimicrobial and antipyretic, [16],[17] cardioprotective, [18] hepatoprotective, [19],[20],[21] antidiabetic, [22],[23],[24],[25],[26] hypolipidemic, [27] anti-arrhythmic, [25],[28] bronchodilatory, [29] anticancer and chemopreventive, [30] antioxidant, [31],[32],[33],[34],[35] immunomodulatory and DNA protective, [36] angiogenesis, [37] protection from ionizing radiation-induced cytogenetic damage, [38] nephrolithiasis, urinary problems, prostatitis, and diuretic, [39],[40],[41],[42],[43],[44] wound and ulcer healing, [45],[46],[47],[48],[49] stress-induced infertility, [50] scorpion bite, [51] mosquito larvicidal activity, [52] antihelminthic, [53] various gastrointestinal disorders, [11] and anticonvulsant. [54],[55] It was also used to improve growth, immune activity, and survival of tilapia fish in fishery sciences [56] and as antihelminthic in veterinary sciences. [57] Agrohomoeopathic use was recorded in terms of its mother tincture having significant effect on radial growth of edible fungus. [58]

Cynodon dactylon was identified as one of the useful weeds in preparing homoeopathic drugs at Chhattisgarh, Madhya Pradesh, India. [59] Regulatory standard of this drug has been mentioned as monograph in the 2 nd volume of Homoeopathic Pharmacopoeia of India, 1974. [60],[61] This plant was identified as one of the potential sources of homoeopathic medicine. [62],[63] The drug was standardized by the Central Council for Research in Homoeopathy (CCRH) at its units in Hyderabad, Ghaziabad, and Lucknow for pharmacognostic, physicochemical, and pharmacological aspects. [64] First homoeopathic proving of this drug was conducted by Dr. Jugal Kishore in 6X, 200X, and mother tincture [65] and later by CCRH in mother tincture, 30C, and 200C potencies. [64],[66],[67] Following that, clinical verifications were carried out by the CCRH and individual practitioners. [64],[68],[69],[70] Enough information about the drug along with its significance, though not elaborative, is given in some of the Homoeopathic Materia Medica. [71],[72],[73]


  Materials and Methods Top


The study was conducted at seven institutes/units of the CCRH: Central Research Institute (H), Noida (Uttar Pradesh); Regional Research Institute (H), Puri (Odisha); Regional Research Institute (H), Shimla (Himachal Pradesh); Regional Research Institute (H), Gudivada (Andhra Pradesh); Regional Research Institute (H), Imphal (Manipur); Clinical Research Unit (H), Port Blair (Andaman and Nicobar Islands); and Clinical Verification Unit (H), Vrindaban (Uttar Pradesh).

As per the inclusion criteria, the patients from all age groups, both sexes, having symptomatic similarity with Cynodon dactylon, and willing to participate were included in the study. If patient was taking any acute medicine, he/she was included in the study after a washout period of 1 week. Exclusion criteria were patients unwilling to participate, patients having a clinical presentation not corresponding with the study medicine, patients on regular medication for any systemic disease, and patients under chronic medicinal treatment. After providing patient information sheet in local vernaculars, informed written consent was obtained from the eligible participants or the guardians in case of minors before participating in the study.

The study medicines were procured from a good manufacturing practice-compliant homoeopathic pharmacy in various potencies, namely, 6C, 30C, 200C, and 1M, and were distributed to above-mentioned institutes/units. First, the presenting signs and symptoms of the patients were recorded in case recording proforma. After that, the symptoms were repertorized using a repertory prepared for clinical verification by the CCRH and then a specially developed Materia Medica [74] was consulted for final selection of the remedy. Later, all these works were incorporated in one book published by CCRH. [64] If the presenting symptoms of the patient corresponded with Cynodon dactylon, then the medicine was prescribed in 6C potency, thrice a day till the improvement or aggravation occurred or for maximum 5-7 days allowing the medicine to act. The medicine was served by corresponding institute/unit pharmacy. In follow-up visits, the changes in signs and symptoms were noted. If there was any sign of improvement, then placebo was prescribed. If there was status quo, next higher potencies such as 30C were prescribed twice a day for 3-5 days in acute diseases or for 5-7 days for chronic diseases, 200C once a week were prescribed and were observed for 2 weeks; and 1M potencies were advised once a fortnight, followed by 2 weeks observation. Dosage was decided as per the need of the case and in accordance with homoeopathic principles. Any potency could be tried for twice only. If adequate responses were not elicited, the cases were restudied and next higher potency was prescribed. If no change was observed even after the change of potencies also, then the case was closed and considered as a clinical failure or status quo. If the patient presented with new symptoms of mild intensity, placebo was prescribed. Appearance of severe symptoms (new or aggravation of existing symptoms) with sufficient strength to cause considerable discomfort to the patient called for a change of medicine or therapy., Such case was considered as a deteriorated one. "Clinical success" was defined a priori as cases showing clinical improvement, objective or subjective, of present complaint(s) as judged by the investigating physician(s) and/or as reported by the patient(s). "Clinical failures" were such cases showing "status quo" and/or worsening or deterioration of the condition, or cases requiring change of medicines. All the data were collected and compiled in specially designed Excel spreadsheet for analysis. Data were presented using descriptive statistics - mean, standard deviations (SDs), absolute values, percentages, and 95% confidence intervals (CIs). As per protocol, a minimum of two prescriptions for each symptom have been considered for enlisting. Prevalence of the symptoms in the responding and nonresponding population was compared using Chi-square or Fisher's exact test, keeping P < 0.05 two-tailed as statistically significant.


  Results Top


A total of 462 patients were enrolled in the study having similar symptomatology with Cynodon dactylon and meeting the pre-specified criteria after screening 25,368 patients from outpatients, for verifying assigned 34 drugs under the clinical verification program of the Council, from October 2005 to March 2010. Of these, 122 dropped out and 340 results were analyzed in the end [Figure 1]. Among the enrolled patients, 204 (60%) were male, rest 136 (40%) were female. The mean age of the patients was 29.7 years (SD = 18.3). Patients spanned all age groups, but majority were from age groups of 19-30 years (n = 103, 30.4%). 261 patients (94.9%) were Hindu, 112 (54.6%) were married, and majority (n = 75, 33.9%) were students by occupation. Mean body mass index (BMI) was 33.1 (SD = 8.9), and most of the patients (n = 85, 42.1%) belonged to obese II BMI range of 35-39.9. Mean height and weight were 150.1 cm (SD = 24.3) and 50.8 kg (SD = 17.8), respectively. Mean systolic and diastolic blood pressures were 117.2 (SD = 12.0) and 75.3 (SD = 7.3) mm Hg, respectively [Table 1]. There were clinical successes in 274 cases (80.6%) and failures in 66 (19.4%), judged subjectively by the physicians. The clinically verified symptoms were enlisted along with the outcomes on the basis of existing proving records and the symptoms available in other literature, and also the new observations (clinical symptoms), those are not mentioned elsewhere but found to be relieved after administration of the medicine [Table 2]. Among the 340 patients, a total of 32 different types of clinical conditions or diagnoses were obtained. Respiratory tract infection (RTI) was the most frequently recorded clinical diagnosis in the responding population (n = 81; 29.6%), followed by haemorrhoids (n = 51; 18.6%), diarrhoea and dysentery (n = 44; 16.1%), rheumatic conditions and myalgia (n = 23; 8.4%), menorrhagia (n = 17; 6.2%), and urolithiasis (n = 11; 4.0%) [Table 3].
Figure 1: The study flow diagram

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Table 1: Sociodemographic features of the patients

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Table 2: List of verified symptoms of the homoeopathic medicine Cynodon dactylon (n=340)

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Table 3: Most frequent clinical diagnoses among the population responding well to Cynodon dactylon (n=274)

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After going through the records, namely, proving symptoms of Cynodon dactylon conducted by the Council and already verified symptoms of the drug emerged from earlier verification of the drug in the Council under the same program, the following were the most frequently observed symptoms:

  • "Dry cough in morning, at night, with irritation and sore throat; aggravation cold air, evening, morning; amelioration. covering or wrapping up warmly, hot drinks, warmth" (n = 52; prevalence 16.4% in the responding group, 95% CI: 12.3, 21.5)
  • "Bleeding and swollen piles" (n = 48, prevalence 14.2% in the responding group, 95% CI: 10.4, 19.1)
  • "Thin, copious, watery, bland nasal discharge; stoppage of nostril, especially left; aggravation morning, reading, sleep; and amel. daytime, open air" (n = 30, prevalence 8.4% in the responding group, 95% CI 5.5, 12.5) [Table 2].


Among the existing symptoms available from other literature, the most frequently observed symptoms were as follows:

  • "Sleep, disturbed, restless" (n = 29, prevalence 7.7% in the responding group, 95% CI: 4.9, 11.6);
  • "Desires company" (n = 27, prevalence 8.0% in the responding group, 95% CI: 5.2, 12.1)
  • "Angry easily, on contradiction, without reason, short-tempered" (n = 26, prevalence 8.4% in the responding group, 95% CI: 5.5, 12.5) [Table 2].


Among new clinical symptoms, the most frequently observed symptoms were as follows:

  • "Tongue, clean" (n = 245, prevalence 70.1% in the responding group, 95% CI: 64.2, 75.4)
  • "Appetite diminished" (n = 124, prevalence 35.4% in the responding group, 95% CI: 29.8, 41.4)
  • "Thermal relation, ambithermal" (n = 100, prevalence 30.7% in the responding group, 95% CI: 25.3, 36.5) [Table 2].


However, there were no statistically significant differences in the prevalence of any of the enlisted symptoms between the responding and nonresponding population [Table 2]. Among the newly observed clinical symptoms, ten were polar - thirst increased versus decreased; tongue clean versus coated; tongue moist versus dry; stool dry, hard versus watery, loose; and sweat scanty versus profuse. RTI and hemorrhoids emerged as the most frequently recorded clinical diagnosis in the responding population [Table 3]. All these findings warrant further research and validation, either by controlled trials and/or by prognostic research.


  Discussion Top


In this observational clinical verification study, a total of 53 symptoms of Cynodon dactylon were verified, of which 43 symptoms were from the proving and clinical verification records, documented after the research carried out previously by the Council and the rest ten were clinical reconfirmation of symptoms from other literature. Besides these, 57 new clinical symptoms were also identified.

Most frequently encountered and improved clinical conditions were RTIs, haemorrhoids, diarrhoea, and dysentery, thus substantiating the traditional uses of Cynodon dactylon. Still, the frequency of prescriptions on the basis of those remained compromised, hindering definite prediction or inference about strength or importance of the symptoms in prescribing the medicine. Currently, likelihood ratio (LR) seems to be the mainstay of future homoeopathic research for confirming the accuracy of the symptoms enlisted under any drug. Retrospective assessment of prevalence and LR of symptoms in good responders could be a mean for better selection of symptoms for prospective research; however, feasibility of conducting such retrospective investigations deserves further discussion. Although the presence and/or absence of Cynodon dactylon symptoms in the "medicine worked" population can be identified in a retrospective way, still finding out the same in the remaining population treated during the study period from the available CCRH database is not feasible; hence, formation of the 2 × 2 contingency table of prognostic research and calculation of LR do not appear to be probable at this point of time. These symptoms of Cynodon dactylon with low prevalence need greater amount of cases to be able to establish a statistically significant LR. All these results should be considered as provisory and need confirmation through prospective research of real prevalence to "tune" homoeopathic medicines' knowledge and more importantly, to increase posterior chance of correct selection of medicine and improve prescription accuracy and clinical outcomes. In addition, we compared responding and nonresponding patients to get some idea of symptoms that can be further investigated; however, no significant difference was obtained in any occasion.

The spheres of action of Cynodon dactylon identified were head, nose, respiratory tract, gastrointestinal system, rectum, genitourinary system, musculoskeletal system, and skin. A few mental symptoms were elicited - getting angry easily, anger on contradiction and without reason; short-tempered; desires company; averse to noise, crowd, music; desire to be alone; irritable; averse to mental or physical work, desire to lie down, profound weakness, lethargy; peevish and quarrelsome. Moreover, our initial observation also elicited few polar symptoms - both desire for and aversion to bitter, fish, and sweet; thirst increased and decreased; tongue clean and coated; tongue moist and dry; sweat scanty and profuse; thermally chilly and hot. Apart from the above observations, during the study, a group of valuable symptoms also emerged reflecting the general characters of the medicine and thereby widening the probable scope of its therapeutic applicability. These newly emerged general symptoms may offer promising help during prescription of Cynodon dactylon. These were desire for salty things and sweets, increased appetite, excessive or decreased thirst, and decreased sweat. The mental features obtained were sad, depressed, melancholic mood; forgetful and weak memory; irritability; and aversion to noise, light, and crowd. These may be considered as useful clinical concomitants or associated symptoms, carrying much importance to prescribe the medicine. The overall results were contributed by different study sites, indicating enhanced generalizability of the study findings. However, being an observational trial, this study cannot address the threats to various internal validity issues, for example, absence of randomization and blinding, the placebo effect, the therapeutic relationship with the clinician (empathy, compassion, social desirability, etc.,), the regression effect toward the mean (RTM), and the use of undisclosed concomitant treatments, if any. Another problem incurred by this clinical verification research is the subjective assessment of clinical success or failure by the investigators, subject to bias. Instead, use of validated generic tools (e.g., Glasgow Homoeopathic Hospital Outcome Scale, numeric rating or visual analog scales measuring intensity of the symptoms under question, quality of life indices, etc.,) would have enhanced the acceptability and interpretation of the findings. The causal association can be tested prospectively and systematically in all cases using modified Naranjo criteria [75] in future studies.


  Conclusions Top


This study was conducted to clinically verify the "symptomatology" of Cynodon dactylon by ascertaining the symptoms improved during verification. A total of 53 symptoms of Cynodon dactylon were verified. Further studies are required to confirm the rest of the symptoms. The findings warrant further evaluation using modified study designs and enhanced methodological rigor. On many occasions, a limited number of prescriptions was generated for specific symptoms making interpretation difficult. Calculation of LR will enable more accurate and quantitative description of strength of the probable or claimed characteristic symptoms of the drug, based on empirical evidence instead of assumption. Hence, further confirmation of the symptoms in larger sample size, analysis of polarity, and prospective estimation of LR of the symptoms using Bayesian statistical methods in routine practice are crucial for inclusion of the symptoms in Homoeopathic Materia Medica and Repertory.

Acknowledgment

We deeply acknowledge Dr. Vikram Singh, Deputy Director, CCRH, Dr. Krishna Singh, Assistant Director, CCRH, and Dr. Subhash Kaushik, Scientist-4, CCRH, for their contribution toward monitoring of data collection from time to time during the study. We gratefully acknowledge the active cooperation and participation made by the patients and the supporting staffs. The authors will also remain grateful to Dr. Lex Rutten and Dr. José Enrique Eizayaga for their significant contributions in improving the manuscript.

Financial Support and Sponsorship

The study was funded by the Central Council for Research in Homoeopathy.

Conflicts of Interest

There are no conflicts of interest.

 
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