| CTRI Number |
CTRI/2025/05/087164 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparison of the effect of two ayurvedic drugs for the treatment of type 2 diabetes
|
|
Scientific Title of Study
|
A comparative experimental and clinical study to evaluate the hypoglycemic efficacy of two ayurvedic drugs Brahmi (Bacopa monnieri Linn.) and Mandukparni (Centella asiatica Linn.) in patients suffering from madhumeha 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 Suresh Kumar Jaiswara |
| Designation |
Reader, Department of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1
A.P.C Road
Kolkata 700009
West Bengal
India
Kolkata
WEST BENGAL
700009
India |
| Phone |
9681098261 |
| Fax |
|
| Email |
dr.sureshkjaiswara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar Jaiswara |
| Designation |
Reader, Department of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1
A.P.C Road
Kolkata 700009
West Bengal
India
WEST BENGAL
700009
India |
| Phone |
9681098261 |
| Fax |
|
| Email |
dr.sureshkjaiswara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Kumar Jaiswara |
| Designation |
Reader, Department of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1
A.P.C Road
Kolkata 700009
West Bengal
India
WEST BENGAL
700009
India |
| Phone |
9681098261 |
| Fax |
|
| Email |
dr.sureshkjaiswara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1
A.P.C Road
Kolkata 700009
West Bengal
India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Jyotiryupa priyadarshinee Samal |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
Department of Dravyaguna Vijnana
Room no t-11
Kolkata
WEST BENGAL |
07008300591
samaljyotirupa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, IPGAER |
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: mandukparni, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmi, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Blood sugar – Fasting greater than 126mg/dl to less than or equal to 200mgdl
PP- Greater than 200mgdl and less than or equal to 350mgdl
Glycated haemoglobin greater than 7 percentage and less than 10 percentage
Recently diagnosed less than 6 month cases of Type 2 diabetes mellitus not taking any diabetes medications
|
|
| ExclusionCriteria |
| Details |
Age below 30 years and above 65 years
Blood sugar Fasting less than or equal 126mgdl and greater than 200mgdl
PP less than or equal to 200mgdl and greater than 350mgdl
Glycated haemoglbin less than or equal to 7 percentage and greater than or equal to 10 percentage
Malignant and accelerated hypertensive
CVS disorder
Pregnant women and planning to be pregnant within 6 months
Lactating mother
Secondary diabetes mellitus
Patients undergoing regular treatment for Diabetes or any other severe illness
CNS disorders
Type 1 diabetes mellitus
Comorbid conditions like ESLD ESRD
Organ dysfunction multiple chronic conditions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be measured based on the clinical outcome measures, bio-chemical outcome measures, safety and tolerability outcome measure to determine and compare the effectiveness and safety of the two-test drugs brahmi and mandukparni for the treatment of madhumeha (type 2 diabetes mellitus) |
56 days (8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effects of both the test drugs changes the quality of life to be assessed after completion of the treatment. |
56 days (8 weeks) |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/06/2025 |
| 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="0"
Months="8"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sureshkjaiswara@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The present study will be single blind double arm interventional clinical study with two groups of patients having newly diagnosed type2 diabetes mellitus in the IPD and OPD of the hospital at the Institute of Post Graduate Ayueveda Education and Research at SVSP, Government of West bengal, Kolkata-700009. The subjective and objective parameters will be assessed with data compilation and stastistical analysis will be carried out. The research aims to provide insights into the safety and efficacy of both the test drugs in managing type 2 Diabetes mellitus ,both in animal models and human subjects. The parameters and outcome measures will help assess and compare the potential of both the test drugs for future clinical applications. |