| CTRI Number |
CTRI/2026/02/104802 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative effect of Rasanjanadi Yoga (hypothetical) and Pramehnashak Yoga on type 2 Diabetes Mellitus w.s.r. Prameha |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study to Evaluate The Efficacy of Rasanjanadi Yoga (Hypothetical) and Pramehnashak Yoga on Type 2 Diabetes Mellitus W.S.R. Prameha |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khushwant Joshi |
| Designation |
Ph.D. Scholar |
| Affiliation |
Keshav Ayurvedic Medical College and Hospital, Aklera, Jhalawar |
| Address |
Department of Kayachikitsa, Keshav Ayurvedic Medical College and Hospital, Aklera, Jhalawar
Jhalawar
RAJASTHAN
326033
India |
| Phone |
9414269342 |
| Fax |
|
| Email |
dr.khushwantjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ravi Sharma |
| Designation |
Professor and Head of Department |
| Affiliation |
Madan Mohan Malviya Govt. Ayurveda College, Udaipur |
| Address |
PG Department of Kayachikitsa, Madan Mohan Malviya Govt. Ayurveda College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414419259 |
| Fax |
|
| Email |
face.udr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ravi Sharma |
| Designation |
Professor and Head of Department |
| Affiliation |
Madan Mohan Malviya Government Ayurveda College, Udaipur |
| Address |
PG Department of Kayachikitsa, Madan Mohan Malviya Government Ayurveda College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414419259 |
| Fax |
|
| Email |
face.udr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Keshav Ayurvedic Medical College and Hospital, Aklera, Jhalawar, Rajasthan 326033 |
|
|
Primary Sponsor
|
| Name |
Dr Khushwant Joshi |
| Address |
Department of Kayachikitsa, Keshav Ayurveda Medical College and Hospital, Aklera, Jhalawar, Rajasthan 326033 |
| 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 |
| Dr Khushwant Joshi |
Keshav Ayurvedic Medical College and Hospital, Aklera, Jhalawar |
Department of Kayachikitsa, Keshav Ayurvedic Medical College and Hospital, Aklera, Jhalawar
Jhalawar
RAJASTHAN |
9414269342
dr.khushwantjoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madan Mohan Malviya Government Ayurveda College Udaipur Rajasthan |
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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Rasanjanadi Yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Hypothetical | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pramehanashak Yoga, Reference: Charak Samhita, Chikitsa Sthan, Chapter 6, Shloka no. 26, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Charak Samhita, Chikitsa Sthan, Chapter 6, Shloka no. 26 |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients which comes under criteria of diagnosis.
2. Patients who agree for the trial and fill the consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 30 years and above 70 years.
2. Pregnant and lactating females.
3. Life threatening conditions [e.g.. Cancer]
4. Type-1 Diabetes mellitus
5. Secondary diabetes i.e., Pancreatitis
6. 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 |
| Change in subjective and objective parameter. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve the Quality of life & wellbeing |
90 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
15/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
THIS STUDY IS A PROSPECTIVE, RANDOMIZED, OPEN-LABEL COMPARATIVE CLINICAL TRIAL DESIGNED TO EVALUATE THE EFFICACY AND SAFETY OF RASANJANADI YOGA IN THE MANAGEMENT OF TYPE 2 DIABETES MELLITUS, CORRELATED WITH PRAMEHA IN AYURVEDIC LITERATURE. A TOTAL OF 100 DIAGNOSED PATIENTS ARE RANDOMLY ALLOCATED INTO TWO EQUAL GROUPS, WITH GROUP A RECEIVING RASANJANADI YOGA AND GROUP B RECEIVING PRAMEHANASHAK YOGA AS THE CONTROL INTERVENTION. THE PRIMARY OUTCOME MEASURES FOCUS ON IMPROVEMENT IN GLYCEMIC CONTROL AND CLINICAL SYMPTOMS OF DIABETES, WHILE SECONDARY OUTCOMES ASSESS SAFETY THROUGH MONITORING ADVERSE DRUG REACTIONS AND THE SUSTAINABILITY OF THERAPEUTIC EFFECTS AFTER TREATMENT COMPLETION. BY INTEGRATING AYURVEDIC PRINCIPLES WITH MODERN CLINICAL ENDPOINTS, THE STUDY AIMS TO SCIENTIFICALLY VALIDATE THE THERAPEUTIC POTENTIAL OF RASANJANADI YOGA AND ESTABLISH A CONCEPTUAL BRIDGE BETWEEN AYURVEDIC MANAGEMENT OF PRAMEHA AND CONTEMPORARY UNDERSTANDING OF DIABETES PATHOPHYSIOLOGY. |