| CTRI Number |
CTRI/2025/11/097613 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of an Ayurvedic medicine for managing diabetes and improving health outcomes linked to chronic high blood sugar |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Ayurvedic Formulation in Managing Madhumeha, Glycaemia, and Clinical Outcomes Secondary to Chronic Glycaemia |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Govind Prasad Gupta |
| Designation |
Professor & Head Department of Roga Viygan |
| Affiliation |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Department of Roga Viygan Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| Fax |
|
| Email |
drguptagovind@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baidyanath Mishra |
| Designation |
Head Healthcare Research |
| Affiliation |
Dabur Research and Development Centre Dabur India limited |
| Address |
Medical Affairs and clinical research 1st floor Dabur Research and Development Centre Dabur India limited Plot no 22 Site 4 Sahibabad
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
911203378606 |
| Fax |
|
| Email |
baidyanath.mishra@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baidyanath Mishra |
| Designation |
Head Healthcare Research |
| Affiliation |
Dabur Research and Development Centre Dabur India limited |
| Address |
Medical Affairs and clinical research 1st floor Dabur Research and Development Centre Dabur India limited Plot no 22 Site 4 Sahibabad
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
911203378606 |
| Fax |
|
| Email |
baidyanath.mishra@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur Research and Development Centre, Dabur India limited, Plot no 22,Site 4, Sahibabad Ghaziabad UTTAR PRADESH201010 India |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
1st floor, Dabur Research and Development Centre, Dabur India limited, Plot no 22,Site 4, Sahibabad Ghaziabad UTTAR PRADESH201010 India |
| Type of Sponsor |
Other [Ayurveda] |
|
|
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 Harish Singhal |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University |
Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Kadwad, Jodhpur–Nagaur Highway Road
Jodhpur
RAJASTHAN |
9636622206
drharishmd@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Sarvepalli Radhakrishnan Rajasthan Post Graduate Ayurved University, Jodhpur Institute of Ayurved Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E139||Other specified diabetes mellituswithout complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: DRDC/2025/015, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: water), Additional Information: drug is patent and proprietary in nature therefore code has been allocated instead full name
(registered name) | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: DRDC/2025/015, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: water), Additional Information: drug is patent and proprietary in nature therefore code has been allocated instead full name
(registered name) |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Signed and dated informed consent. 2) Age between 30 years to 70 years (both inclusive) 3) Confirmed cases of hyperglycaemia without any comorbidity/complications with random blood sugar between more than equal to 170 mgperdl to less than equal to 250 mgperdl with or without OHAs. 4) Levels of Hb1Ac above 5.7percent. 5) Confirmed cases of three consecutive high blood sugar levels |
|
| ExclusionCriteria |
| Details |
Patients unwilling to give informed consent. 2) Uncontrolled hyperglycaemia morethan 250 mgperdl with OHA and insulin therapy. 3) Multiple organ failure or ambulatory cases. 4) History of unstable angina, myocardial infarction, cerebrovascular accident, renal/hepatic failure, oncotherapy, high-dose steroids, or severe respiratory disorders. 5) Women with missed menstruation over 3 months, on hormone therapy for pregnancy or known pregnancy cases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in random blood sugar levels.
Changes in hyperglycaemia symptoms (weakness (daurbalya), tremors (kampa), tingling (hasthpada chimchimayana), numbness (suktata)).
Changes in urination symptoms (urination frequency (muhurmuhu pravritti), burning urination (daha), foaming urination (fena).
Changes in HbA1c levels.
Changes in fasting plasma insulin.
|
Week 0 screening, week 4, week 12, week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in BMI.
Changes in lipid profiles.
Safety monitoring (Adverse events)
|
Week 0 screening, week 4, week 12, week 16 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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 Yet Recruiting |
| 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
|
Objective: Objective
of this study is to assess the efficacy and safety of an Ayurvedic Formulation
in improving the condition of Madhumeha by managing glycaemia and enhancing
clinical outcomes related to chronic glycaemia. This will be an open label, two arm, prospective
clinical study to evaluate efficacy and safety study having two dose groups of at
least 25 subjects each. After obtaining ethics committee
approval and registering the study on the Clinical Trial Registry of India
(CTRI), eligible participants aged 30–70 years as known cases of hyperglycaemia
with or without OHAs will be screened and enrolled. There will be four visits
per subject. On visit 1, subjects who consent to participate in the study will
be screened based on inclusion-exclusion criteria and undergo a Physical &
systemic examination. After obtaining ethics committee
approval and registering the study on the Clinical Trial Registry of India
(CTRI), eligible participants aged 30–70 years as known cases of hyperglycaemia
with or without OHAs will be screened and enrolled. There will be four visits
per subject. On visit 1, subjects who consent to participate in the study will
be screened based on inclusion-exclusion criteria and undergo a Physical &
systemic examination. Trial participants will then be allocated to trial treatment for a duration of 4 months active treatment. |