| CTRI Number |
CTRI/2024/09/074389 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mustadi kwatha will be given to Patients of Diabetes Mellitus. |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Mustadi kwatha and Ghavati in Madhumeha (Diabetes Mellitus Type-2) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikrant Kumar |
| Designation |
Pg Scholar Kayachikitsa Department |
| Affiliation |
Uttarakhand Ayurved University, Gurukul Campus Haridwar |
| Address |
OPD No. 5 Department of Kayachikitsa, Uttarakhand Ayurved University, Gurukul Campus Haridwar 249404 India.
OPD No. 5 Department of Kayachikitsa, Uttarakhand Ayurved University, Gurukul Campus Haridwar 249404 India.
Hardwar
UTTARANCHAL
249404
India |
| Phone |
09568325329 |
| Fax |
|
| Email |
vikrantkumar11061997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Punita Pandey |
| Designation |
Professor |
| Affiliation |
Uttarakhand Ayurved University, Gurukul Campus Haridwar |
| Address |
OPD No. 5 Department of Kayachikitsa, Uttarakhand Ayurved University, Gurukul Campus Haridwar 249404 India.
OPD No. 5 Department of Kayachikitsa, Uttarakhand Ayurved University, Gurukul Campus Haridwar 249404 India.
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9319394485 |
| Fax |
|
| Email |
pandey.punita62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikrant Kumar |
| Designation |
Pg Scholar Kayachikitsa Department |
| Affiliation |
Uttarakhand Ayurved University, Gurukul Campus Haridwar |
| Address |
OPD No. 5 Department of Kayachikitsa, Uttarakhand Ayurved University, Gurukul Campus Haridwar 249404 India.
OPD No. 5 Department of Kayachikitsa, Uttarakhand Ayurved University, Gurukul Campus Haridwar 249404 India.
Hardwar
UTTARANCHAL
249404
India |
| Phone |
09568325329 |
| Fax |
|
| Email |
vikrantkumar11061997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vikrant Kumar Pg Department of Kayachikitsa, Uttarakhand Ayurved University, Gurukul Campus Haridwar 249404 India |
|
|
Primary Sponsor
|
| Name |
Vikrant Kumar |
| Address |
Pg Department of Kayachikitsa, Uttarakhand Ayurved University, Gurukul Campus Haridwar |
| 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 |
| Vikrant Kumar |
Uttarakhand Ayurved University, Gurukul Campus Haridwar |
OPD No. 5 Department of Kayachikitsa Uttarakhand Ayurved University, Gurukul Campus Haridwar
Hardwar
UTTARANCHAL |
09568325329
vikrantkumar11061997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Uttarakhand Ayurved University, Gurukul Campus, Hardwar. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: mustadi kwatha, Reference: charak sutra sthana chapter 23 and shloka number 12 and 13, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: mustadi kwatha ghanavati, Reference: charak sutra sthana chapter 23 and shloka number 12 and 13, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Fasting blood glucose level (FBS) more than or equal 126mg/dl to less than or equal 350mg/dl.
2. Post prandial blood sugar level (PPBS) more than or equal to 200mg/dl to less than or equal to 410mg/dl.
3. HbA1c more than or equal to 6.5 percentage to less than and equal to 13 percentage.
4. Known case of diabetes mellitus type 2. |
|
| ExclusionCriteria |
| Details |
1. Patients of type 1 Diabetes Mellitus.
2. Chronicity more than 10 year.
3. Blood sugar- fasting blood sugar level more 350mg/dl.
4. Post Prandial blood sugar level more 410mg/dl.
5. Patients having complications.
6. Patients suffering from any serious medical or surgical illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
relief in subjective parameters.
1. Prabhutmutrata (Polyuria)
2. Trishnadhikya (Polydipsia)
3. Kshudhadhikya (Polyphagia)
4. Atinidra/ Nidradhikya (Increased sleep)
5. Kara-pada-taladaha (Burning sensation of both palms and feet)
6. Kara-pada-talasuptata (Numbness of both palms and feet)
|
4-6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
relief in objective parameters.
• Fasting blood glucose level (FBS) equal or more than 126mg/dl & equal or less than350mg/dl.
• Post prandial blood sugar level (PPBS) equal or more than200mg/dl & equal or less than 410mg/dl.
• HbA1c equal or more than 6.5% & equal and less than 13% |
assessment will be done on 0th day , 30 day , 60 day and 90th day, for FBS and PPBS. And Hba1c will be done on 0th day and 90 day. |
|
|
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)
|
30/09/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is COMPARATIVE CLINICAL EVALUATION OF MUSTADI KWATHA & GHANVATI IN MADHUMEHA (DIABETES MELLITUS TYPE-2) for age group between 20-65 years, for 90 days. The study will be conducted at UAU gurukul campus, Haridwar on 40 patients. in this study 20 patients will be administered mustadi kwatha and 20 patient will be administerd mustadi ghana vati for 90 days. The assessment will be done on the basis of subjective and objective parameters. The study will be conducted at OPD/IPD level of P.G department of kayachikitsa. The assessment will be done at the interval of 30 days of the clinical trial and the results obtained will be tabulated and statically analyzed using appropriate tests. |