| CTRI Number |
CTRI/2019/07/020363 [Registered on: 25/07/2019] Trial Registered Prospectively |
| Last Modified On: |
10/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Roll of ayurveda medicine in the management of Madhumeha (Diabetes) |
|
Scientific Title of Study
|
A conceptual and comparative clinical study of Madhumehari Churna and Madhumehari Ghrit in the Management of Madhumeha . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KEDAR LAL MEENA |
| Designation |
PROFESSOR and HOD |
| Affiliation |
national institute of ayurveda |
| Address |
Room no 121 Maulik Siddhant Department National Institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8318802228 |
| Fax |
|
| Email |
drkedar01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KEDAR LAL MEENA |
| Designation |
PROFESSOR and HOD |
| Affiliation |
national institute of ayurveda |
| Address |
Room.no.121 Maulik Siddhant Department, National Institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8318802228 |
| Fax |
|
| Email |
drkedar01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRADEEP SAROJ |
| Designation |
P.G.SCHOLAR |
| Affiliation |
national institute of ayurveda |
| Address |
Room.no.121 Maulik Siddhant Department, National Institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8318802228 |
| Fax |
|
| Email |
rajpradeep74@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA,MADHAV VILAS HOSPITAL,JORAWAR SINGH GATE JAIPUR RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
MADHAV VILAS HOSPITAL,NEAR JORAWAR SING GATE JAIPUR RAJASTHAN |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PRADEEP |
NATIONAL INSTITUTE OF AYURVEDA |
ROOM.NO.07 MADHAV VILAS HOSPITAL, NEAR JORAWAR SING GATE,JAIPUR RAJASTHAN
Jaipur
RAJASTHAN |
8318802228
rajpradeep74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Madhumehari churna |
6 gm bd before meal,FOR 2 MONTH |
| Intervention |
MADHUMEHARI GHRITA |
5 GM BD BEFORE MEAL,FOR 2 MONTH |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Presence of cardinal symptoms of Madhumeha described in Ayurveda texts.
2.Confirmed cases of DM type II on the basis of laboratory investigations.
3.Patients having F.B.S. level ranges between 110 – 150 mg/dl and P.P. B.S. between 141 – 200 mg/dl.
|
|
| ExclusionCriteria |
| Details |
1.Patient having age below 20 and above 70 years.
2.Patient suffering from complication of DM.
3.Patient having Type-I DM (IDDM).
4.Patient having Type-II DM with any other serious systemic disease.
5.Patient having a FBS more than 150 mg/dl and PPBS more than 200 mg/dl.
6.Patient with lipid profile not in normal range.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Madhumehari Ghrit in the management of madhumeha |
2 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To compare the effect of Madhumehari Ghrit and standard drug Madhumehari churna . |
2 MONTH |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
INTRODUCTION Ayurveda is science of life as it explains (the conditions of) the life. The purpose of science of life is maintenance of the health and alleviation of disease, of one that is ailing. This science of treatment is taught for the benefit of life. As life in the modern era has becomes more commercialized and mechanical. The tendencies of a person has been changed a lot with respect to himself that’s why the lifestyle disorders like heart disease, diabetes, cancer etc. are now mostly seen. Incurable and chronic diseases are increasing in the society because of irregular diet pattern and stress conditions; one of them is Madhumeha, Which is mentioned in classical Ayurvedic texts. It can be co-related with DM (diabetes mellitus), which is a growing health hazard in developing countries like India. Madhumeha is a type of 20 type of Premeha .Which come under type of Vataj Prameha . The Samprapti (pathogenesis) and Nidan was described in Charaka Samhita Nidan 4 and the Chikitsa of madhumeha described in ch.chi.6. In ch.chi.6/34 “सिदà¥à¤§à¤¾à¤¨à¤¿ तैलानि घृतानि चैव देयानि मेहेषà¥à¤µà¤¨à¤¿à¤²à¤¾à¤¤à¥à¤®à¤•à¥‡à¤·à¥ …†Charaka described that due to the dominance of vata in madhumeha medicated sneha should be use for getting better result because sneha is best remedy for vata .So i choose to internal use of madhumehari ghrit in the management of madhumeha .The ghrit will be prepaired with madhumehari churna which is attested and estabilished drug in madhumeha. Madhumeha is a type of 20 type of Premeha .Which come under type of Vataj Prameha . The Samprapti (pathogenesis) and Nidan was described in Charaka Samhita Nidan 4 and the Chikitsa of madhumeha described in ch.chi.6. In ch.chi.6/34 “सिदà¥à¤§à¤¾à¤¨à¤¿ तैलानि घृतानि चैव देयानि मेहेषà¥à¤µà¤¨à¤¿à¤²à¤¾à¤¤à¥à¤®à¤•à¥‡à¤·à¥ …†Charaka described that due to the dominance of vata in madhumeha medicated sneha should be use for getting better result because sneha is best remedy for vata .So i choose to internal use of madhumehari ghrit in the management of madhumeha .The ghrit will be prepaired with madhumehari churna which is attested and estabilished drug in madhumeha. NEED OF STUDY As the madhumeha is burning problem today there is need to study deeply and implement the Ayurvedic principles in treatment of madhumeha as there are no side effects. Ayurvedic treatment is of less value, without knowing its exact cause, as Samprapti Vighatana can only be done when we know its cause and how the patho-physiology happens. Hypothesis:- Null hypothesis:- The effect of Madhumehari Churna equal with Madumehari Ghrit. Alternetive hypothesis:- Either Madhumehari Ghrit effectiveness more or less than Madhumehari Churna. AIMS & OBJECTIVES To evaluate the effect of Madhumehari Ghrit in the management of madhumeha. To compare the effect of Madhumehari Ghrit and standard drug Madhumehari churna . MATERIALS AND METHODS Materials:- For present study two types of materials will be utilized as categorized below. 1.Literary material: - Reference will be collected from classical Ayurvedic texts as well from previous research works/thesis, research articles from internet and modern science texts to explain fundamental principles. 2.Clinical material: - clinical study will be done on the patients of Madhumeha in two groups to fulfill the above said objectives. A. Patient:- Patient fulfilling all the selection criteria, visiting OPD, IPD of NIA and Bombaywala hospital, Jaipur. B. Laboratory:- Assistance will be taken from central lab of NIA, Jaipur. C. Drug:- Drug will be purchased and prepared through pharmacy of NIA, Jaipur. METHODS The main criteria of diagnosis of the patient will be based on the cardinal and associated signs, symptoms and investigations of the disease based on the Ayurvedic and modern texts. CLINICAL STUDY A clinical study will be done as under - Administration of Drug 40 clinically diagnosed patients will be randomly divided into 2 Groups of 20 each as below:- In first group 20 patients will be administered Madhumehari churna in the dose of 5 gms. before meal 2 times a day with water for 2 months. In second group 20 patients will be administered Madhumehari Ghrit in the dose of 6 grams before meal 2 times a day with lukewarm water for 2 months. Criteria for the assessment: The effect of trial drug will be assessed in terms of Subjective & Laboratory parameters Subjective assessment- All the patients registered for clinical trial will be asked for any changes in their clinical manifestations. Objective assessment- 1.Blood sugar level – Fasting and Post prandial. 2.Lab investigations- CBC, E.S.R. 3.Urine test for blood sugar in urine. 4.Lipid profile. These investigations will be carried out for the diagnosis of Madhumeha and to exclude any other systemic complications. DURATION- For 2 months DIRECTION AND DIET- As mentioned in classical Ayurvedic text. FOLLOW UP- All the patients will be reviewed after each 15 days for a period of 2 months. During the trial and follow up study the patients will be assessed on the basis of following parameters- Subjective improvement Objective improvement
Subjective improvement
All the patients registered for the present trial will be looked for any improvement in the symptoms mentioned in Ayurveda and modern texts and changes in their health. if any, produced after the course of therapy. Objective improvement
Various signs mentioned in Ayurveda texts and modern sciences will be looked into for any imprvement after the course of therapy.
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