| CTRI Number |
CTRI/2024/05/067442 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of diabetes with Ayuvedic medicine |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Haritaki Vati versus Metformin in Patients of Type 2 Diabetes Mellitus (Madhumeha): A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashvini Dinesh Pardhekar |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and research Center Deemed to be University Wardha |
| Address |
Datta Meghe Institute of Higher Education and research Center Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Hirapur Wardha
OPD and IPD of Kayachikitsa Department
MGACH & RC Salod (H),Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8329737457 |
| Fax |
|
| Email |
ashupardhekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashvini Dinesh Pardhekar |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and research Center |
| Address |
Datta Meghe Institute of Higher Education and research Center Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Hirapur Wardha
OPD and IPD of Kayachikitsa Department
MGACH & RC Salod (H),Wardha
MAHARASHTRA
442001
India |
| Phone |
8329737457 |
| Fax |
|
| Email |
ashupardhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashvini Dinesh Pardhekar |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and research Center |
| Address |
Datta Meghe Institute of Higher Education and research Center Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Hirapur Wardha
OPD and IPD of Kayachikitsa Department
MGACH & RC Salod (H),Wardha
MAHARASHTRA
442001
India |
| Phone |
8329737457 |
| Fax |
|
| Email |
ashupardhekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| The subjects will be recruited from Kayachikitsa OPD and IPD of Mahatma Gandhi Ayurved
College Hospital snd Research Centre Salod Hirapur Wardha and special multidiagnostic Camp |
|
|
Primary Sponsor
|
| Name |
Ashvini Dinesh Pardhekar |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Hirapur Wardha 442001 |
| 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 |
| Ashvini Dinesh Pardhekar |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha 442001 |
OPD and IPD of
Department of
Kayachikitsa
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
8329737457
ashupardhekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Center Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tablet Metformin | Tablet Metformin 250 mg/500 mg Twice a day before meal for 60 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki Vati, Reference: Bhaishajyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having fasting blood sugar level more than 126 mg/dl and/0r post prandial blood sugar level more than 200mg/dl |
|
| ExclusionCriteria |
| Details |
Fasting Blood sugar level ≥200 mg/dl
Post Prandial Blood Sugar Level ≥300 mg/dl
Pregnant and lactating women.
Patients with acute complications like cirrhosis of liver, Pancreatitis, and Hypoglycemic shock.
Patients with chronic complications like Nephropathy, Retinopathy and Neuropathy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief of symptoms of madhumeha with Fasting and Post meal Blood sugar level became normal |
Fasting and Post meal Blood sugar level became normal |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 Randomized single-blind standard control non-inferiority trial comparing the clinical efficacy of Haritaki Vati 1 gm twice a day with honey before meal and Tablet Metformin 250/500 mg twice a day with water before meal for 60 days in 30 patients(15 in each group), the primari outcome will measure by investigationg Fasting and Post Meal blood suger level before and after completion of treatment duration. |