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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: -
2Comparator ArmDrugClassical(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”  

  

 
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