| CTRI Number |
CTRI/2025/04/084679 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to evaluate the efficacy of Chandrakala gutika and Mamajjaka Ghanavati in the management of madhumeha with special reference to Diabetes Mellitus type II. |
|
Scientific Title of Study
|
Randomised comparative clinical trial to evaluate the efficacy of Chandrakala gutika and Mamajjaka Ghanavati in the management of madhumeha with special reference to Diabetes Mellitus type II |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chinmayi MK |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Deemed to be university, Jaipur |
| Address |
Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India
Jaipur RAJASTHAN 302002 India |
| Phone |
8971894622 |
| Fax |
|
| Email |
chinmayimk98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajay Kumar Sahu Sir |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be university, Jaipur |
| Address |
Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India
Jaipur RAJASTHAN 302002 India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajay Kumar Sahu Sir |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be university, Jaipur |
| Address |
Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India
Jaipur RAJASTHAN 302002 India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India |
|
|
Primary Sponsor
|
| Name |
National institute of ayurveda |
| Address |
Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 CHINMAYI MK |
Hospital, National Institute of Ayurveda, Deemed to be university, Jaipur |
OPD No 1, 18, 22, 25, Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India
Jaipur
Rajasthan Jaipur RAJASTHAN |
8971894622
chinmayimk98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee - National institute of ayurveda |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandrakala Gutika, Reference: Bhaishajya Ratnavali, Prameha prakarana , sloka no. 67-68, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mamajjaka Ghana Vati, Reference: Bhaishajya Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient aged between 30 to 65 years
2. Patient having symptoms of Madhumeha
3. Patient with diagnosed cases of DM-II
4. Patient with FBS in range of 126mg/dl to 250mg/dl and PPBS in range of 200mg/dl to 350 mg/dl or both and HbA1c less than 10%
5. Patient consuming oral-hypoglycemic agents for a duration more than 1 year and having poor glycemic control
6. Patient with chronicity less than 5 years
7. Patient with willingness to participate in the study and provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Patient with type 1 diabetes
3. Patient with FBS more than 250mg/dl
PPBS more than 350 mg/dl
4. Patients with Madhumeha upadrava or asadhya laxana
5. Patients with DM 2 on insulin therapy and Drug induced diabetes mellitus
6. Patients with hepatic impairment.
7. Uncontrolled hypertension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study will be the change in FBS/PPBS levels from baseline to the end of the treatment period. |
Baseline to the end of the treatment period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes will include changes subjective parameters, HbA1c, liver function tests, renal function tests, and incidence of adverse events |
Baseline, 45th day ,end of the treatment period.
HbA1c-Baseline to the end of the treatment period.
|
|
|
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 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="1" Months="6" Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Diabetes mellitus (DM) is
defined as a disturbance of intermediary metabolism, manifesting as a chronic
sustained hyperglycemia primarily due to either an absolute or relative lack
of insulin. It is a metabolic disorder
characterized by polyuria, polydipsia, weight loss, fatigue etc., sometimes
associated with complications of retina, kidney, and nervous system. India has already become the “ Diabetes Capital” of the world, with over
3 crore affected patients, which is a tip of iceberg. Despite the availability of conventional treatments
like Metformin, achieving optimal glycemic control in T2DM remains a challenge
for many patients. Additionally, concerns regarding side effects and long-term
sustainability of pharmacological interventions signifies the need for
exploring alternative therapies. Though there are so many ongoing and completed
studies on efficacy of Ayurvedic management of DM, most of them shows is effective in
reducing the subjective parameters and no much change is observed in FBS,
PPBS and is recommended to carry out the study in a larger number of patients.
Investigating the efficacy of Chandrakala
gutika in comparison to Mamajjaka Ghanavati offers an opportunity to diversify treatment options and
potentially improve outcomes. Therefore, keeping all these facts in mind, it has been decided to conduct a clinical study entitled as “RANDOMISED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF CHANDRAKALA GUTIKA AND MAMAJJAKA GHANAVATI IN THE MANAGEMENT OF MADHUMEHA WITH SPECIAL REFERENCE TO DIABETES MELLITUS TYPE II”
|