| CTRI Number |
CTRI/2026/01/101591 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Pramehnil Tablet an Ayurvedic formulation in disease of kaphaj prameha or type 2 Diabetes |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial to evaluate the efficacy and safety of Pramehnil Tablet an Ayurvedic formulation in management of Kaphaj Prameha w.s.r.to type 2 Diabetes Mellitus |
| 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.Kirti Sachdeva |
| Designation |
Phd Scholar |
| Affiliation |
M.S.Regional Ayurveda Research Institute |
| Address |
Room no.1, Hospital building, MJF Ayurvedic college harota chomu
Jaipur
RAJASTHAN
303702
India |
| Phone |
9772057774 |
| Fax |
|
| Email |
kirtiayurveda2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAvinash Kumar Jain |
| Designation |
Research officer |
| Affiliation |
M.S.Regional Ayurveda Research Institute |
| Address |
M.S.Regional Ayurveda Research Institute Jhotwara Road Indra Colony Bani Park
Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
07425063398 |
| Fax |
|
| Email |
vaidyaakjain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kirti Sachdeva |
| Designation |
Phd Scholar |
| Affiliation |
M.S.Regional Ayurveda Research Institute,jaipur |
| Address |
Room no.1 ,Hospital building ,MJF Ayurvedic college harota chomu
Jaipur
RAJASTHAN
303702
India |
| Phone |
9772057774 |
| Fax |
|
| Email |
kirtiayurveda2012@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kirti Sachdeva |
| Address |
Room No.1, Hospital Building ,MJF Ayurvedic college,harota ,chomu ,303702 |
| 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 |
| DrKirti Sachdeva |
MJF Ayurvedic medical college harota chomu |
Room no 1 MJF Ayurvedic college harota chomu
Jaipur
RAJASTHAN |
9772057774
kirtiayurveda2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF MSRARI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. 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: Pramehnil Tablet , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: BGR 34, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient freshly diagnosed or already diagnosed between the age of 30 years to 70 years with HbA1c range between 6.5 to 9 also having symptoms pf type 2 DM or kaphaj prameha and willing to give consent for participation |
|
| ExclusionCriteria |
| Details |
Patient not willing to give consent below the age of 30 and above the age of 70 with high HbA1c more than 9 also having complication of type 2 DM like neuropathy retinopathy nephrophathy also patient of type 1 DM Pancreatitis any other serious medical condition like malignancy pregnent and lactating mothers also excluded |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in value of HbA1C |
At the end if trial means on 90th day and 120th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in symptoms on DSQ (DIABETES SYMPTOMS QUESTIONNAIRE
Change in fasting & pp sugar |
On baseline,15th day,30th,45th day, 60th day, 75th day at on 90th day,120th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/02/2026 |
| 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="10"
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
|
It is a randomised ,prospective ,open label ,interventional controlled clinical trial.The trial consist of two groups ,one will receive trial drug Pramehnil tablet and second group will receive control drug BGR 34. Chane in the subjective and objective parameters of kaphaj prameha or type 2 DM will be the end point of study |