| CTRI Number |
CTRI/2026/02/103221 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Nimbaphala Vati In Madhumeha |
|
Scientific Title of Study
|
OPEN LABEL SINGLE ARM CLINICAL STUDY ON EFFICACY OF
NIMBAPHALA VATI (Azadirachta indica Juss) AS MADHUMEHAHARA
(ANTIDIABETIC ACTIVITY) IN TYPE II 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 MOUNESHWAR P PATTAR |
| Designation |
PG SCHOLAR |
| Affiliation |
|
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan
Hassan
KARNATAKA
587201
India |
| Phone |
7026203030 |
| Fax |
|
| Email |
mouneshpp123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MOUNESHWAR P PATTAR |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan
Hassan
KARNATAKA
587201
India |
| Phone |
7026203030 |
| Fax |
|
| Email |
mouneshpp123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MOUNESHWAR P PATTAR |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan
Hassan
KARNATAKA
587201
India |
| Phone |
7026203030 |
| Fax |
|
| Email |
mouneshpp123@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital Hassan Karnataka 573201 India |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital |
| Address |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital B M road Thanniruhalla Hassan |
| Type of Sponsor |
Private 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 |
| Dr Mouneshwar P Pattar |
SDM College of Ayurveda and Hospital Hassan |
OPD No 6 Department of Kayachikitsa MAdhumeha
Sri Dharmasthala Manjunatheshwara College of ayurveda and Hospital Thanniruhalla BM Road Hassan Karnataka
Hassan
KARNATAKA |
7026203030
mouneshpp123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Institutional Ethical Committee |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NIMBA PHALA VATI, Reference: BHAVAPRAKASH , Route: Oral, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: USHNA JALA ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects above 30 years up to 60 years of either gender suffering from Type 2 Diabetes Mellitus will be taken.
Fasting Blood Sugar MORE THAN OR EQUAL TO 126 mg/dL.
Post Prandial Blood Sugar MORE THAN OR EQUAL TO 200 mg/dL.
Those patients willing to participate in the study and who are ready to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
Subjects with Type 2 Diabetes Mellitus who are on insulin.
Subjects With Diabetic complications like Diagnosed Diabetic foot, Diagnosed Diabetic Retinopathy, Diagnosed Diabetic Neuropathy, Diagnosed Diabetic Nephropathy and other secondary complications.
Patients with impaired Cardiac, Hepatic and Renal Functions.
Pregnant and Lactating woman. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Madhumehahara Karma of Nimba Phala Vati as Madhumehahara Karma in Type 2 Diabetes Mellitus |
3 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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 synopsis proposes an open-label, single-arm clinical study to evaluate the antidiabetic (Madhumehahara) effect of Nimba Phala Vati prepared from Azadirachta indica (neem fruit) in patients with type 2 diabetes mellitus aged 30–60 years. Thirty patients with FBS > 126 mg/dL and PPBS > 200 mg/dL will receive Nimba Phala Vati 1 g/day in two divided doses before food for 30 days, and changes in Madhumeha symptoms plus FBS, PPBS, FUS and PPUS between day 0 and day 31 will be assessed. PPBS, FUS and PPUS between day 0 and day 31 will be assessed.The protocol includes pharmacognostic and analytical standardization of Nimba Phala and the Vati, predefined inclusion/exclusion criteria, ADR monitoring and reporting via Ayush Suraksha, allowance for rescue and concomitant medications, and statistical |