| CTRI Number |
CTRI/2026/01/101493 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of kiratikta churna in diabetes mellitus patients |
|
Scientific Title of Study
|
Evaluate The Effectiveness of Kiratikta Churna in Disintegration of Pathogenesis in various prakriti of Type 2 Diabetes Mellitus patients – Single Arm Study |
| 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 Bhola Ram Dhakad |
| Designation |
PG Scholar Department of Rog Nidan Evam Vikriti Vigyana |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar,Najafgarh, New Delhi |
| Address |
Room no -143B,PG Department of Rog Nidan Evam Vikriti Vigyana
Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar,Najafgarh, New Delhi – 110073
South West
DELHI
110073
India |
| Phone |
8109832522 |
| Fax |
|
| Email |
bholu912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Kumar Sapra |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar,Najafgarh, New Delhi |
| Address |
Room no -214,PG Department of Rog Nidan Evam Vikriti Vigyana
Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar,Najafgarh, New Delhi – 110073
South West
DELHI
110073
India |
| Phone |
8588943505 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Kumar Sapra |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar,Najafgarh, New Delhi |
| Address |
Room no -214,PG Department of Rog Nidan Evam Vikriti Vigyana
Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar,Najafgarh, New Delhi – 110073
South West
DELHI
110073
India |
| Phone |
8588943505 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan,khera dabar New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar,Najafgarh New Delhi-110073 |
| 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 |
| Dr Bhola Ram Dhakad |
Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh, New Delhi |
Room no- 143B, PG Department of Rog Nidan Evam Vikriti Vigyana
Ch. Brahm Prakash Ayurved Charak Sansthan
Khera Dabar, New Delhi – 110073
South West
DELHI |
8109832522
bholu912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
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 | Classical | | (1) Medicine Name: kiratikta churna , Reference: Pathyapathya-Vibodhakah, Nighantuh of Kaiyadeva, edited by Prof. Priyavrata Sharma and Dr. Guru Prasad Sharma published by Chaukhambha Orientalia,kritanna varga, shlok-1, page no. 401, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of either gender of age equal to or above 21 and eual to or below 65 years
2) Patients with fasting blood sugar more than or equal to 126 mg/dl
3) Patients with PPBS more than or equal to 200 mg/dl to less than or equal to 350 mg/dl
4) Patients with classical signs and symptoms of type 2 Diabetes mellitus with RBS more than or equal to 200 mg/dl to less than or equal to 350 mg/dl
5) Patients with HbA1c 6.4 to 8.0
6) Newly diagnosed patients (within one year)
7) Patients willing to provide consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women and lactating mothers.
2. known case of Type 1 Diabetes Mellitus.
3. Patients with serious hepatic, cardiac or renal disorders or having any other co-morbidities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Glycated Haemoglobin (HbA1c) Levels:
Change in HbA1c levels from baseline to the end of the treatment period will be assessed.
2) Postprandial Glucose Levels
3) FBS
|
Day 1th Day 20th Day 40th Day 60th
evaluation will be done before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Patient-Reported Outcomes:
Assessment of subjective criteria, and treatment satisfaction through patient-reported outcome measures related to diabetes mellitus.
2. The observation of prevalence of the disease among patients was assessed by other possible data of age, sex, education, family history, economic status, occupation, life style, food habits etc.
|
Day 0th Day 20th Day 40th Day 60th |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
05/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 single-arm clinical study aims to evaluate the effectiveness of Kiratikta Churna in disintegrating the pathogenesis (Samprapti Vighatana) of Type 2 Diabetes Mellitus (Madhumeha) in patients of different Prakriti. A total of 102 diagnosed T2DM patients aged 21–65 years will be enrolled and administered Kiratikta Churna 3 g twice daily after meals for 60 days. Prakriti assessment will be done using the NCISM Prakriti Parikshan App. The study will assess changes in HbA1c, fasting blood sugar, post-prandial blood sugar, and classical symptoms of Madhumeha. The outcomes will help understand the prakriti-based therapeutic response of Kiratikta Churna. Statistical analysis will be carried out to determine the clinical significance of the intervention. |