Comparative Study of Guduchi Satva and Nishatriphala Yog in Management of Madhumeha A Clinical Study

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1 Journal of Pharmaceutical and Biological Sciences ISSN: ; CODEN: JPBSEV Published by Atom and Cell Publishers All Rights Reserved Available online at: Case Study Comparative Study of Guduchi Satva and Nishatriphala Yog in Management of Madhumeha A Clinical Study Dr Kavita Ramchandra Ugale, Maharashtra University of Health Science, Department of Kayachikitsa, NAMC, Nallasopara East, Maharashtra, India ABSTRACT Received: / Revised Accepted: / Published: Madhumeha that is Diabetes mellitus is a leading health hazard across the world. The busy and worried life of modern era, the excessive heavy diet, excessive use of sugar and jaggery and their product, lack of physical exercise, has open the door fo the predisposition of Madhumeha (diabetis mellitus). In this research study total 40 patients were selected out of which 20 patient group A was given Giloya satva, the starch material of the stem of a wellknown single drug Guduchi (Tinospora cordifollia} Whereas, 20 patient of group B was given Nishatriphala yog a combination of fine powder of five drugs that is Nisha (Haridara and Daruharidara), Triphala (Amalki, Haritaki and Bhibitak). For this study, the 40 patients were diagnosed on the basis of clinical features described in Ayurvedic text along with laboratory finding. Severity of signs and symptoms was recorded on the basis of Gradation. The clinical symptomes were recorded before and after administration of drug in a 7 days followup and Laboratory test Blood sugar fasting and postprandial was carried out. Keywords: Madhumeha, diabetis mellitus, Guduchi satva, Nishatriphalayog INTRODUCTION Madhumeha (or ojomeha) is a disease where ojas or bala is inefficently produced and execreted with urine due to vitiated vayu, particulary its kashaya and ruksha properties thus prime object of its treatment must be to protect and promote oja or bala along with the control over vitiated vayu. In an Ayurvedic classics there are number of herbs and herbal compound along with metallic compounds for the management of Madhumeha. In this research work the drug with madhur rasa Vipaka, rasayan and balya properties is the choice from the Jivaniya drug called Guduchi for the treatment of Madhumeha. Guduchi or giloya satva, the starch material of the stem is a well-known single drug formulation obtained from the drug Guduchi (Tinospora cordifollia) satva kalpana of herbal drug being the milstone in the development of ayurvedic pharmaceutic.. In this global era it has a great important due to high palatability & more efficacy in minimum dose. Whereas, the another group is Nishatriphala yog a combination of fine powder of five drugs i.e Nisha ( Haridara & Daruharidara), Triphala (Amalki, Haritaki & Bhibitak). These five drugs are easily available at reasonable cost which is effordable even for the low economic status patients. The above five drugs in which Triphala with pancharasa (except lavan rasa), madhur vipaka has Tridoshhar

2 & Rasayan properties whereas Haridara & Daruharidara are Tikta katu rasa pradhan katu vipaka & ushna virya has kaphagna medhogna properties. In prameha meda is considered as main dushya & kapha plays predominanti role. (बह द रव श ल ष म द ष ववश ष:!) In madhumeh kapha aswell as vata are responsible for the disease. So the combination of Tridoshar, Rasayan & Kaphagna dravya of resonable cost certainly encourage me to choose Nishatriphala yog. MERIAL AND METHODES Drug Preparation In group A Guduchi satva was prepared as described in Bhavaprakash Nighantu. The dried powder was filled in capsule with the help of machine to make 500 mg of capsule. In group B- Nishatriphal yoga (Haridra, Daruharidara, Haritaki, Bhibitaki and Amalki) Kanda of Haridara, Daruharidara and fruits of Haritki, Bibhitaki and Amalki seedless pulp (majja) was taken. The powder of all five powder was mixed in equal quantity and packets measuring 10gms each were made. Conduct of Clinical Trial Study Design: Open label, Randomized, Comparative study Type of Trial: Efficacy Trial No of Object: 40 (20 patient in each group) Duration: 49 days Name of Drugs: Grp A- Guduchi satva- 500mg BD, Kala Ubhay bhojanpurva, Anupan- Koshna jal; Grp B- Nishatriphala yoga -10gm BD - ubhay bhojanpurva, Anupan Koshna jal Inclusive Criteria: Patient of madhumeha according to textual sings & symptoms 1. Prabhutmutrata 2. Aavilmutrata 3. Kshudhadhikya 4.Trishnadhikya 5.Karpadadaha 6. Daurbalyanubhuti 7. Dantadinam maladhyam 8. Madhurasyata 9. Swedaadhikya 10. Chikkanata dehe Exclusive criteria: 1. Gestational diabetis 2. Diabetis Mellitus type- 1(Insulin dependent Diabetis Mellitus) 3. Diabetic ketoacidosis 4 Diabetic retinopathis, 5 Diabetic nephropathy 6. Hypertension & ischaemic heart disease 7. Diabetic coma 8. Prameha pidikas. 9. Follow up of after 7 days, 10. Consent A consent from the patient for the study. Clinical Evalution - For this study, the 40 patients were diagnosed on the basis of clinical features described in Ayurvedic text along with laboratory finding. Severity of signs and symptoms was recorded on the basis of Gradation. The clinical symptomes were recorded before administration of drug termed as () on every follow-up & termed as After treatment i.e ().Dropped out cases were not included in the statistical analysis. Subjective parameters The effect of drug under clinical trial was based on 10 cardinal symptoms. Scoring pattern of symptoms for the assessment of results was done on gradation basis. The gradation are as follows Prabhuta Mutrata (Increased quantity of urine) Grade times in day and no micturation of night Grade times in day and 1-2 times at night Grade times in day and 2-4 times at night Grade times day and 2-4 times at night. Aavil mutrata - (Turbidity of urine) Grade 1 -Present Grade 0 -Absent Kshudhadhikya (Polyphagia) Grade 0-2 times meal and 1 breakfast per day Grade 1-2 times meal and 2 breakfast per day 66

3 Grade 2-2 times meal and 3-4 breakfast per day Grade 3-2 times meal and 4 or more breakfast per day Trishnadhikya (Except water intake with meal) (Polydipsia) Grade glasses per day Grade glasses per day Grade glasses per day Grade 3-9 or more glasses per day Karapada daha (Burning sensation of the soles of palms) Grade 0 -No burning sensation of palms and sole Grade 1 -Mild burning sensation of palms and sole Grade 2 -Moderate burning sensation of palms and sole Grade 3 -Severe burning sensation of palms and sole Daurbhalyanubhuti (Lethargy) Grade 0 -Performance of daily routine without any complaints Grade 1 -Slight mild weakness while performing daily routine Grade 2 -Moderate weakness while performing daily routine Grade 3 -Not able to perform daily routine or severe weakness Dantadinam maladhyatvam (Stickyness of mouth) Grade 0 -Present Grade 1 -Absent Madhurasyata (Sweetness of mouth) Grade 0 -No sweet sensation in mouth Grade 1 -Mild sweet sensation early in the morning or office sleep Grade 2 -Moderate sweet sensation throughout the day Grade 3 -Severe sweet sensation throughout the day Swedadhikya (Excessive seating) Grade 0 -No sweating Grade 1 -Mild sweating Grade 2 -Moderate sweating Grade 3 -Severe sweating with four smelling Chikkanata Dehe (Smooth and shiny skin) Grade 0 -No complaints Grade 1 -Mild complaints Grade 2 -Moderate complaints Criteria for assessment of result: The total effect and comparative effect of therapy was assessed statisticaly in following terms- Effect % of relief in sign & symptoms 1. Cured % 2. Improved -- > 50% 3. Fair % 4. Unchanged --< 25% Grade 3 -Severecomplaint Objective Parameters - Laboratory test Blood sugar fasting and postprandial was carried out.these investigations were repeated after every 20 days for the assessment. True Blood Sugar (Venous blood) mg/dl normal Suggestive Diagnostic range Fasting >120 Post-prandial >170 Patients having positive blood sugar level ie above normal range were included in the study. Blood sugar level < 250 mg were taken into consideration. Diet regimen During the period of treatment patients were advised to take their usual diet with special instructions. Statistical Analysis - The interpretation of result done with the help of statistical analysis. The effect of trial drug on 40 67

4 Madhumeha patients was assessed by applying following tests. Annova Test- Krushkal Wallis Test with Dunn s Multiple & Comparision Test is a type of annova test RESULTS Unpaired t-test - For comparative assessment of effect of trial drug on both subjective & objective parameters Paired t-test - For the individual assessment of objective parameter Table- 1 Total % of Relief due to effect of therapy on symptoms of Madhumeha in groups A & B Symptoms Groups A Groups B Prabhutmutrata 94.5% 87.5% Aavil mutrata 77.78% 72.72% Kshudadhikya 80% 88.70% Trishnadhikya 73.68% 80% Karpadaaha 60.60% 80% Daurbalyanubhuti 84.37% 77.14% Dantadinam maladhyam 90.90% 92.30% Madhuaryata 86.66% 100% Swedadhikya 85.57% 88.89% Chikkanta deha 76.9% 66.66% Total 81.04% 83.39% 120% 100% 80% 60% 40% 100% 94.50% 92.30% 87.50% 88.70% 90.90% 77.78% 80% 84.37% 86.66% 88.89% 85.57% 80% 80% 77.14% 76.90% 73.68% 72.72% 66.66% 60.60% Group A Group B 20% 0% Prabhutmutrata Aavil mutrata Kshudadhikya Trishnadhikya Karpadaaha Daurbalyanubhuti Dantadinam maladhyam Madhuaryata Swedadhikya Chikkanta deha Symptoms 68

5 MEAN MEDIAN Total effect of therapy on Blood Sugar Level Fasting by Mann whiteny Test ( A Paired t-test) 2) BLOOD SUGAR LEVEL FASTING (mg/dl) STD DEVIION STD ERROR SUM P-VALUE SUMMARY GR-A GR-B GR-A GR-B GR-A GR-B GR-A GR-B GR-A GR-B GR-A * GR-B ** INVESTIGIVE PARAMETERS BLOOD SUGAR LEVEL-FASTING mg / dl BLOOD SUGAR LEVEL-FASTING GR-A GR-B The total effect of therapy on Blood Sugar Level Fasting was evaluated with the help Mann Whitney test (Paired t-test) before treatment mean SD in experimental group (A) was after treatment is reduces to , P - value was < 0.05 suggested significant result in the decrease in Blood Sugar Level Fasting after completion of treatment. In group B before treatment mean SD was after treatment is reduces to , P- value was < 0.01 suggesting more significant reduction in the score of Blood Sugar Level Fasting after completion of treatment. 69

6 Mean Median Std Deviation Std Error Sum Total effect of therapy on Blood Sugar Level Postmeal by Mann Whiteny Test (Paired t-test) P-Value Summary 3) BLOOD SUGAR LEVEL -POST MEAL (mg/dl) GR-A GR-B GR-A GR-B GR-A GR-B GR-A GR-B GR-A GR-B GR-A *** GR-B ** BLOOD SUGAR LEVEL POST MEAL mg /dl BLOOD SUGAR LEVEL POST MEAL GR-A GR-B The total effect of therapy on Blood Sugar Level Postmeal was evaluated with the help of Mann Whiteny test (Paired t- test) before treatment mean SD in experiemntal group A was after treatment it reduces to , P - value was < suggested Highly significant result in the decrease in Blood Sugar Level Postmeal after completion of treatment. In group B before treatment mean SD was after treatment is reduces to , P- value was < 0.01 suggesting More significant result in decrease in Blood Sugar Level Postmeal after completion of treatment. 70

7 Mean Median Std Deviation Std Error Sum P-Value Summary Total effect of therapy on Urine Sugar Level Fasting by Mann Whiteny Test (Paired t-test) 4) URINE SUGAR LEVEL FASTING (mg/dl) GR-A GR-B GR-A GR-B 0 0 GR-A GR-B GR-A GR-B GR-A GR-B GR-A * GR-B ns URINE SUGAR-FASTING mg / dl GR-A GR-B URINE SUGAR-FASTING The total effect of therapy on Urine Sugar Level Fasting was evaluated with the help of Mann Whiteny test (Paired t-test) before treatment mean SD in experiemntal group (A) was after treatment is reduces to , P - value was < 0.05 suggested significant result in the decrease in Urine Sugar Level Fasting after completion of treatment.in group B before treatment mean SD was after treatment is reduces to , P- value was > 0.05 suggesting nonsignificant result indecrease in Urine Sugar Level Fasting after completion of treatment. 71

8 Total effect of therapy on Urine Sugar Level Postmeal by Mann Whiteny Test (Paired t-test) 5) URINE SUGAR LEVEL -POST MEAL (mg/dl) Mean Median Std Deviation Std Error Sum P-Value Summary GR-A GR-B GR-A GR-B GR-A GR-B GR-A GR-B GR-A GR-B GR-A * GR-B * URINE SUGAR-POST MEAL MEAN GR-A GR-B 0 URINE SUGAR-POST MEAL The total effect of therapy on Urine Sugar Level Postmeal was evaluated with the help of Kushkal Wallis Test with Dunn s multiple comparision test before treatment mean SD in experiemntal group (A) was after treatment is reduces to , P - value was < 0.05 suggested significant result in decrease of Urine Sugar Level Postmeal after completion of treatment. In group B before treatment mean SD was after treatment is reduces to , P- value was < 0.05 suggesting Significant result in the decrease in Urine Sugar Level Postmeal after completion of treatment. 72

9 COMPARIVE STUDY Table 6 Comparative effect of trial drugs on symptoms of 40 patients of Madhumeha by un-paired t-test Symptoms Group A Group B M ± SEM M ± SEM Probability Prabhutamutrata ± ± P > 0.05(NS) Aavil mutrata 0.7 ± ± 0.23 P > 0.05(NS) Kshudhadhikya ± ± 0.26 P > 0.05(NS) Trishnadhikya 1.4 ± ± P > 0.05(NS) Karapadadaha 1.34 ± ± P > 0.05(NS) Daurbalyanubhuti 1.8 ± ± P > 0.05(NS) Dantadinamaladhyam ± ± P > 0.05(NS) Madhurasyata 1 ± ± 0 P > 0.05(NS) Swedadhikya 1.22 ± ± P > 0.05(NS) Chikanata Deha 1.25 ± ± P > 0.05(NS) Total comparative effect of therapy of both group Nishatriphalayog and Guduchi satva on 40 patient by applying unpaired T-test. The difference in Mean and standard error of both group (M SEM) through which probability from t-value was calculated which found >0.05 in both A & B suggested non-significant in all symptoms in both group i.e. After comparative study we conclude that the both drugs are effective equally on the symptoms of Madhumeha of 40 patients Table 7 Comparative effect on investigatory parameters of 40 patients of Madhumeha byunpaired t-test Investigation Group A Group B M ± SEM M ± SEM Probability Blood sugar (Fasting) ± ± P > 0.05 Blood sugar (Post Meal) ± ± P > 0.05 Urine sugar (Fasting) 0.38 ± ± P < 0.05 Urine sugar (Post Meal) ± ± P < 0.01 Total comparative effect of therapy on objective Parameter of both group i.gr A Nishatriphalayog and Grp B Guduchi satva on 40 patient of Madhumeha by applying unpaired T-test. The difference in Mean and standard error of both group (M SEM) through which probability from t- value was calculated,which found P>0.05 in Blood sugar level(f&pp) of the patients of both group, suggesting non-significant difference in both group on blood sugar level so we conclude that both the drugs are equally effective on blood sugar level DISCUSSION Observe difference in terms of percentage of relief for the symptoms in both group is non-significant, but in the group A percentage relief for symtoms prabhutmutrata, Aavil Mutraa, Daurbalyaanubhuti,Cikkanata Deha,is more than groupb, and in group B percentage of relief for symptoms Kshudaadhikya, Karpaddaha, Dantanam Maladhyam, Madhurasyata, Swedadhikya is more than group A. Total Percentage of Relief in group B is more than Group A. Hence the overall percentagewise group B is better than group A. Comparative Effect of therapy on Investigatory paremeter by Unpaired t- test we conclude that: atistically Non- Significant (i.e P<0.05) result was found in blood sugar level (fasting &Postmeal) of 73

10 the patient in group A & B at the end of the study. Individual assessment of the effect of therapy on Investigatory parameter by Paired t test we conclude that: Satistically on individual assessment shows significant effect on decrease in blood sugar level in the patients of Madhumeha of both group A& B Conclusion- Hence from above observation it is concluded that: The review of literature from classical Ayurvedic texts reveals that the concept of aetiopathogeness, clinical presentation and principles of management of Madhumeha bears a resemblance with that of noninsulin dependent Diabetes Mellitus. Agni has important role in Madhumeha (Pachakagni, Bhutagni and Dhatvagani). The correction of various agni in Madhumeha is a part of the treatment. Prime object of treatment of Madhumeha is to protect oja or bala and control over vitiated vayu with Bahudravata of kaph. 74 Clinical study of Nishatriphala yog and Guduchi satva shows statistically significant favorable result on clinical symptoms but highly significant result on two symptoms o Prabhutmutrata & o Daurbalyanubhuti Significant result in decrease in blood sugar level and urine sugar level (Fasting and postmeal) on individual assessment. After comparative study of effect of both the groups we concluded - While comparing both groups the observed difference between the results of both groups in term of subjective parameter is nonsignificant. Hence both the group are equally potent in the management of Madhumeha. While, considering objective parameters, blood sugar level decreased in both group but this decrease is non-significant for both group. Thus at the end of this study we can conclude that both the drugs are Agni deepak, Dhatuposak, Balya, Rasayan, Easily available, No side and adverse effect. REFERENCES 1. Ayurvedacharya Vevimadham Shashtri Joshi, Ayurvedia Shabdakosh, Maharashtra Rajya Shatirya and Sanskriti Mandal, Mumbai Kaviraj Ambika datta Shastri Edited by Shri Rajeshwardatta Shastri, Bhaisajya Ratnavali,, 14 th Edition 2001 Chaukhamba Sanskrit Sansthan, Varanasi. 3. Laxmipati Shasti, Yogratnakar, 7 th edition, published by Chaukhamba, Sanskrit, Sansthan Varanasi K.C. Chunekar, Bhavprakash Nighantu,, published by Choukhamba Sanskrit Sansthan, Varanasi, Chraka and Dradhabala edited with Charaka Chandrika comm by Brahmanand Tripathi,, Charak Samhita,, published by Choukhamba Sanskrit Sansthan, Varanasi, Dr. Anant Ram Sharma, Sushrut Samhita, by Chaukhamba, Surbharti prakashan, Varanasi., Anant Damodar Athansale, Astang Sangraha, Shrimal Atachya, prakashan, Pune, by Dr. Brahmanand Tripathi,, Astang Hridaya, Chaukhamba Sanskrit Prakashan, Delhi Acharya priyavat Sharma, Dravya Guna Vigyana, published by Chaukhamba Bharati, Academy Varanasi 10. Nadkarni, AK, Indian Materia Medica, Popular book depot, Mumbai, Dr. Prakash Paranjpe, Indian Medicinal plants, published by Chaukhamba sanskrit pratishtan, Delhi, 2001.