Study Design:-Open trial, Single group assignment, Safety/Efficacy study.

Transcription

1 Title of Study-Evaluation of Therapeutic effect of Vitamrit-SF syrup in certain body disorders like in, General Debility, Loss of Appetite, General body weakness, Enhance Protein Metabolism, Poor immunity system, Body stress & mental stress & adverse effect of the preparations Vitamrit-SF is an Ayurvedic Proprietary Medicine. Study Design:-Open trial, Single group assignment, Safety/Efficacy study. Study Done at:--g.n.d.u.ayurvedic Dispensary, Amritsar Formulation:-Approved by Director of Ayurveda. Duration of study:-60 Days. Study Began on:-may 2011 Study completed on:-july 2011 Manufacturing Licence-HP-126-Ay. Aims & Objectives:- 1-To evaluate the efficacy of syrup Vitamrit-SF in patients with body disorders like, General debility, Ageing, Poor immunity, Body Stress, Mental stress. 2-To study the effect of the drug on some subjective criteria e.g. feeling of well being, ability to do work, fatigability, body weight etc. 3- To study adverse effects of the drug if any. Drug Review:-In Ayurveda, General Debility means the lack of strength of human beings. In Ayurveda strength is called Bala & it is described as immunities. Charak has used the word, Vyaadhi akham & Vyadhi kshamatwa. Those who are capable to tolerating diseases are called Vyadhi kshamatwa i.e. resistance to disease. Those who cannot tolerate disease measurable & immediate affected by them are called. Vyadhi akham, which is symptoms to general debility or general weakness (lack of strength). 1

2 The formulation for this study is sugar free syrup named Vitamrit-SF syrup prepared by the aqueous & distilled extracts of some herbs those are repeatedly mentioned in the classical texts for curing body s disorders. Symptoms:-Weakness is very common symptom. The feeling of weakness may be subjective(the person feels weak,but has no measurable loss of strength)or concrete measurable loss of strength, weakness may be generalized(total body weakness) or localized to specific area side of the body, limb & so on, As subjective feeling of weakness usually is generalized & association with infection diseases. Weakness is particularly important when it occurs only in one area of the body. There is a vast description about the debility & their cure. In Ayurveda there are a lot of references of herbs with their therapeutic values in general debility. The formulation for this study named, Vitamin -SF, prepared by the decoction of some herbs, those are repeatedly mentioned in the classical text books for curing, General Debility. 2

3 Composition of syrup-vitamrit -SF Each 5 ml contains:- Sr.No. Name of Ingredient Quantity 1 Ashwagandha 150 mg. 2 Guduchi 100 mg. 3 Amla 100 mg. 4 Vidarikand 75 mg. 5 Bala Panchang 75 mg. 6 Shatavari 50mg. 7 Mulethi 50 mg. 8 Punarnava 50 mg. 9 Musli 50 mg. 10 Bahera 50 mg 11 Gokshur 50 mg. 12 Harar 25 mg. Distilled Extracts of 13 Brahmi 100 mg. 14 Jivanti 75 mg 15 Trikatu 75 mg 3

4 16 Kalmegh 75 mg 17 Arjun 75 mg. 18 Bhumiamalki 75 mg. The formulation for this study in syrup named, Vitamrit-SF, prepared by the aqueous & distilled extract of some herbs; those are repeatedly mentioned in the classical texts for curing, General Debility. Dosage & Duration of Trial:-As for dosage & duration of the treatment is concerned the treatment with the, Vitamrit-SF, 2-3 T.S.F., three times a day, is therapeutically potent & safe. Indications:-General Debility, Loss of appetite, weakness, general body weakness, ageing, poor immunity system, irregular metabolism, body stress, mental stress, convalescence, chronic fatigue,low immunity induced health disorders. Safe for diabetic patients. Selection of cases:-the patient were selected from the O.P.D. of G.N.D.U.Ayu.Dispensary, Amritsar.20 patients were registered for the study. Inclusion Criteria:- 1-Health with associated symptoms like general debility, ageing, poor immunity system, irregular metabolism, body stress & mental stress. 2-All patients in the age group of years (Both males & females) were selected. Exclusion Criteria:- 1-Patients not willing for trial. 2-Patients below the age of 18 & above age of 65 years. 3-Patients with some gross disease expecting addition of some more medicine for proper management & complication of disease. 4

5 Material & Methods:-It was an open trial method with one group only.written & informed consents of patients were taken before registration for the study.a case history shhet was prepared to note down all the details of the patients & the diseases.after registeration,detailed history was taken which was followed physical & systemic examination.laboratory investigations done at the time of inclusion of patient in trial were also recorded in this performa. Dietary Advice Patients were advised to avoid the excess intake of fast foods, oily, fatty substances which leads to many health disorders like obesity, hypertension, hypotension, heart disease due to rise of cholesterol level etc. Lukewarm water drinking is beneficial to improve digestion. Regular drinking of hot water helps to bring lightness to the body & improves flexibility in the muscles. Follow Up:-All patients were followed up after every 15 days for 6o days.any change in signs & symptoms as well as in hematological indices & other investigational parameters were recorded if needed.patients were questioned directly for any untoward side effects encountered since & during the course of trial. Statistical Data(According to Sex) Sr. No. Sex No. of Patients 1 Male 10 2 Female 10 Statistical Data (According to Age) Sr. No. Sex No. of Patients 1 Between Between Above

6 Statistical Data(According to age) Sr.No. Diet No.of Patients 1 Vegetarian 18 2 NonVegetarian 2 Criteria of Assessment:- During the trial & follow up studies the patients were assessed on following parameters:- 1-Subjective improvement 2-Clinicale valuations. Observations:- Following observations were noted before, during & after the study. Days Day 0 Day15 Day30 Day 45 Day 60 Symptoms Weakness Fatigability Heartburn Body Stress Indigestion Adverse Effect

7 Discussions:- As far as individual symptoms are concerned here is a brief discussion. Weakness:-This symptom improved remarkably by the treatment of 60 days. Out of 20 patients with this symptom at the start of the treatment all except one showed complete improvement. The improvement was highly significant by just 15 days treatment & there was more improvement & sustained effect of further treatment of 60 days. Loss of appetite:-:-a significant number of 18 patients were feeling well after treatment. Fatigability:-The symptom fatigability was gone in 83% of affected patients after the treatment of 60 days. Heartburn:-Out of 9 patients with this problem, only one did not get any relief by the treatment. Rest all had completely recovered. Body Stress:-A significant number of 19 out of 20 patients were feeling well after treatment. Indigestion:-All the 18 patients were feeling well after the treatment. Adverse Effect of Drug:-Along with the therapeutic effects of the, Vitamrit-SF, the same was observed for any ill effects, no any subjective, clinical, hematological & adverse effects were observed by the treatment. Results & Conclusion 1-The syrup Vitamrit-SF is significant in therapeutic action in general debility, weakness, loss of appetite, general body weakness, enhance protein metabolism & provides strength in digestion, reducing fatigue, ageing, body stress & mental stress. 2-The effect of the drug on subjective criteria like feeling of well being, ability to do work & fatigability was favorably significant. 3-No significant changes were observed in the hematological criteria in subjects with normal parameters 7

8 4-No adverse effect was noted by the administration of syrup Vitamrit-SF, for one month continuously with dosage of 2-3 T.S.F., thrice a day, so it is safe to use this preparation in this dose & duration. 8