| CTRI Number |
CTRI/2019/06/019763 [Registered on: 19/06/2019] Trial Registered Prospectively |
| Last Modified On: |
23/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Ayurvedic management on daibetes milletus type 2 |
|
Scientific Title of Study
|
An open randomised controlled clinical trial of katak-khadiradi ghanvati and traykantak ghrita matrabasti in madhumeha with special refrence to diabetes mellitus type 2 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mugdha Aveenash Vaidya |
| Designation |
PG SCHOLAR |
| Affiliation |
Ymt ayurvedic medical college and hospital |
| Address |
Ymt ayurvedic medical college and hospital, 1st floor Kayachikitsa Department institutional area,sector 4, kharghar,navi mumbai ,Pin code-410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7875420200 |
| Fax |
|
| Email |
13mugdha.vaidya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minal Vaidya |
| Designation |
Professor |
| Affiliation |
Ymt ayurvedic medical college and hospital |
| Address |
Ymt ayurvedic medical college and hospital, 1st floor Kayachikitsa Department institutional area,sector 4, kharghar,navi mumbai ,Pin code-410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
09323790371 |
| Fax |
|
| Email |
drminalsvaidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Minal Vaidya |
| Designation |
Professor |
| Affiliation |
Ymt ayurvedic medical college and hospital |
| Address |
Ymt ayurvedic medical college and hospital, 1st floor Kayachikitsa Department institutional area,sector 4, kharghar,navi mumbai ,Pin code-410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
09323790371 |
| Fax |
|
| Email |
drminalsvaidya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mugdha Aveenash Vaidya |
| Address |
Samarth udyog mandir, shivaji nagar, vengaon road, dahivai, krjat, dist- raigarh, 410201 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mugdha Aveenash Vaidya |
YMT Ayurvedic Medical College and Hospital |
Ymt ayurvedic medical college and hospital, 1st floor Kayachikitsa Department institutional area,sector 4, kharghar,navi mumbai ,Pin code-410210
Raigarh
MAHARASHTRA |
7875420200
13mugdha.vaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Katakkhadiradi ghanvati
Traikantak ghrita
|
Ghanvati – 4 gm twice a day – before food
Matrabasti – 48ml i.e. 50 ml for 9 days in each month for 3 months
|
| Intervention |
Katakkhadiradi ghanvati |
Ghanvati – 4 gm twice a day – before food
|
| Comparator Agent |
Tab metformin – 500mg bd |
Tab metformin – 500mg bd
For three months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Recently diagnosed patients of Type 2 DM.
patients irrespective of gender will be included & who are willing to take medicine.
Age group within 18-80 yrs.
Patients with fasting blood sugar level upto 350 mg/dl & post Prandial upto 450 mg/dl with presence of urine in sugar.
Patients with HbA1C value 6.5 to 9 %
Few signs & symptoms of Diabetes Mellitus.
|
|
| ExclusionCriteria |
| Details |
K/C/O Type 1 diabetes mellitus.
Gestational diabetes.
K/C/O BPH.
K/C/O Ketoacidosis, Diabetic coma, acute infections any where in the body and Gangrene.
Patients on insulin and steroid therapy.
Patients with any major systemic diseases like Carcinoma, Tuberculosis etc.
K/C/O Immunocompromised patients or patients on immunosuppressive drugs.
Emergency conditions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assesment of the efficacy of katakkhadiradi ghanvati and traykantak ghrita matrabasti in madhumeha. |
Assesment of the efficacy of katakkhadiradi ghanvati and traykantak ghrita matrabasti in madhumeha.
Follow up after every month and assessed by BSL fasting and postprandial test and final result will be assessed after 3 months as the HbA1c is criteria
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Katak Khadiradi ghanvati and Traykantak ghrita matrabasti are not effective or equivalent in management of Madhumeha. |
Ghanvati– 4 gm twice a day – before food
Matrabasti – 48ml i.e. 50 ml for 9 days in each month for 3 months
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/06/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
HYPOTHESIS- Katak Khadiradi ghanvati and Traiykantak ghrita matra basti are more effective in management of Madhumeha than Metformin.
TRIAL GROUP DRUG- Katak Khadiradi ghanvati - katak,khadir,dhatri,vairi,samanga,vidul,rajani,patha,chutbeej,abhaya,abda Traiykantak ghrita matra basti - trikantak,ela,pashanbhed,yashtimadhu,shatavari,darbha,draksha,ushir,pippali,punarva,kash,ikshu,matsyakshi.vashir,shilajit,ghrut,dugdha
METHOD OF PREPARATION - Katak Khadiradi ghanvati : For the preparation of 40ml kwath :-20 gm coarse powder (having size of 0.5 to 1 cm) of all contents then 320 ml water add in it then Put it on mandagni then remaining of 50 ml kwath then Filter with help of 20mm mesh sieve then 50 ml kwath prepared. After again reheated it and 4gm of Ghanavati is formed. Preparation of Matra-basti- 2kg of contents taken then 8 lit of water is added then It is heated on mandagni to reduce it upto 4lit then 1 kg of Goghrita is taken and melted on mandagni then 125gm of kalka dravyas that is same as that of kwath dravya are added into it then 1 lit of Godugdha and 4 lit of kwath are added in it after that It is heated until Snehasidhdhi lakshana are achieved
CONTROLL GROUP DRUG - METFORMIN
RESULT WILL BE ASSESSED ON THE BASIS ON HBA1C IN DAIBETES MELLITUS TYPE 2 |