| CTRI Number |
CTRI/2025/12/098974 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Test the Effect of Distillated Cow Urine Treated Wheat Flour on Blood Sugar in Diabetes Patients |
|
Scientific Title of Study
|
Analytical Study & Randomized Comparative Trial of Gomutra Ark Bhavita Godhuma in the Management of 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 |
Swati |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda, DeNoVo JAIPUR |
| Address |
Room no. 201 Department of Swasthavritta and Yoga, National Institute of Ayurveda DeNoVo, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
06398049846 |
| Fax |
|
| Email |
swati57parjesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Agrawal |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
Room no. 201 Department of Swasthavritta and Yoga, National Institute of Ayurveda DeNoVo, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SWATI |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
Room no. 201 Department of Swasthavritta and Yoga, National Institute of Ayurveda DeNoVo, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
6398049846 |
| Fax |
|
| Email |
swati57parjesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Funded under Intuitional research grant,National Institute of Ayurveda DeNoVo, Jorawar Singh Gate,Amer Road,Jaipur,India 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda DeNovo |
| Address |
Funded under Intuitional research grant,National Institute of Ayurveda DeNoVo, Jorawar Singh Gate,Amer Road,Jaipur,India 302002 |
| 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 Swati |
NATIONAL INSTITUTE OF AYURVEDA |
OPD No. 21 DEPARTMENT OF SWASTHAVRITTA AND YOGA, NATIONAL INSTITUTE OF AYURVEDA, DENOVO JAIPUR
Jaipur
RAJASTHAN |
06398049846
swati57parjesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Ahar- Gomutra Ark Bhavita Godhuma as a diet in form of roti and Madumehari Churna dose 6gm twice a day before meal with lukewarm water.
• Method of intervention – 150 gm flour/ day, 5 Days in a week
, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: MADHUMEHARI CHURNA , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Luke warm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age group 18 - 70 years, newly diagnosed Type 2 Diabetes Mellitus of either sex.
FBS 126mg/dl – 200mg/dl and PPBS 180mg/dl – 280mg/dl and HbA1c range between 6.5% - 10%
Patient willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from Type 1 Diabetes Mellitus and other complications of diabetes such as Diabetic neuropathy, Diabetic Retinopathy, Ischemic heart disease.
Patient with cardiovascular disease and other systemic illness.
Pregnant women and lactating mother.
Patients taking allopathic medications
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in HBA1C Level
|
Baseline and week 12
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in fasting blood sugar,
Post Prandial blood sugar |
Baseline and week 12 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/12/2025 |
| 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="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 study aims to evaluate the effect of Gomutra Ark Bhavita Godhuma, a cow urine processed wheat formulation, in the management of Type 2 Diabetes Mellitus. The study is divided into two phases. Phase 1 includes analytical testing of treated wheat to assess nutritional changes, carbohydrate fraction, starch and protein digestibility, mineral content, and antidiabetic enzyme inhibition. Phase 2 is a randomized open label comparative clinical trial with two groups of newly diagnosed Type 2 Diabetes Mellitus patients. The trial group will receive Gomutra Ark Bhavita Godhuma as diet along with Madhumehari Churna. The comparative group will receive only Madhumehari Churna with their normal diet. A total of 80 participants, 40 in each group, will be studied for a period of 90 days. Primary outcomes include changes in fasting blood sugar, postprandial blood sugar, and HbA1c levels. Secondary outcomes include analytical findings related to glycemic properties. The study aims to provide scientific evidence on whether Gomutra Ark Bhavita Godhuma can serve as an effective dietary support in the management of Type 2 Diabetes Mellitus. |