| CTRI Number |
CTRI/2026/01/100117 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| 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 effect of Madhumehavinashini Gutika and Jwarahara Kashaya on Blood sugar levels in adults with type 2 Diabetes Mellitus. |
|
Scientific Title of Study
|
Randomized comparative clinical trial To evaluate the efficacy of Madhumehavinashini Gutika with and without Jwarahara Kashaya 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 |
Shalini |
| 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 |
| Phone |
8905001209 |
| Fax |
|
| Email |
vermashalini099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Sahu Sir |
| Designation |
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 |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Sahu Sir |
| Designation |
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 |
| 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
|
|
|
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 Shalini |
Hospital, National Institute of Ayurveda, Deemed to be university, Jaipur |
OPD No 1, 18,7 Department of Kayachikitsa, National
Institute of Ayurveda, Deemed to be university, Near Jorawar Singh
gate, Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN |
08905001209
vermashalini099@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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Madhumehavinashini Gutika, Reference: Rasamrit, shloka no.125,126 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 375(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jwarahara Kashaya, Reference: anubhoota yoga of NIA Formulary , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhumehavinashini Gutika, Reference: Rasamrit, shloka no.125,126, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 375(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Jwarahara Kashaya), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between age group 30-65 years
2.Patient having signs and symptoms of Madhumeha
3.Diagnosed cases of Type 2 Diabetes Mellitus
4.Patient with FBS –in range of 126-250mg/dl OR
5.PPBS-in range of 160-350mg/dl OR BOTH
6.Patients on Oral hypo-glycemic drugs for a duration less than or equal to 1 year with poor glycemic control.(as mentioned in above points)
7.Willingness to participate in the study and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women
2.Patients having Type-1 Diabetes Mellitus.
3.FBS more than 250 mg/dl and PPBS more than 350 mg/dl.
4.Patients of Type-2 diabetes mellitus who are on insulin therapy and Drug induced diabetes mellitus.
5.Type-2 diabetes mellitus with complications and Madhumeha with Ashadhya upadrava
6.History of hypersensitivity or allergy to study drugs
7.Uncontrolled hypertension (systolic blood pressure more than 180 mmHg or diastolic blood pressure more than 100 mmHg)
8.Presence of any other serious medical condition that may interfere with study participation
|
|
|
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 in subjective parameters and incidence of adverse events. |
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)
|
01/06/2026 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a clinical syndrome characterized by hyperglycemia
due to absolute or relative deficiency of insulin. It is characterized by
polyuria, polydipsia, polyphagia, fatigue etc. It is one of the
lifestyle disorders whose prevalence is rising more rapid in almost all
countries. It is a leading cause of morbidity and mortality all over the world. Despite the
availability of treatments like oral hypoglycemic agents, achieving optimal
glycemic control remains challenging for many patients. The long-term
effectiveness and side effects of pharmacological interventions can make managing T2DM even more complex, thus
emphasizing 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. So Conducting
larger clinical trials with well-defined objective measures like FBS,
PPBS, and other biomarkers could help
validate the effectiveness of these therapies and potentially expand treatment
options for patients with T2DM. Investigating the efficacy of Jwarahara Kashaya in comparison to Madhumehavinashini gutika offers an
opportunity to potentially improve
outcomes. 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 MADHUMEHAVINASHINI GUTIKA WITH AND WITHOUT JWARAHARA KASHAYA IN
THE MANAGEMENT OF MADHUMEHA WITH SPECIAL REFERENCE TO DIABETES
MELLITUS TYPE II”
|