| CTRI Number |
CTRI/2025/08/093176 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of gokshurguggulu vati in the management of high blood sugar level in diabetes patients in comparison with the tablet metformin |
|
Scientific Title of Study
|
A randomised controlled clinical trial to study efficacy of gokshurguggulu vati with tablet metformin in the management of madhumeha with special reference to hyperglycaemia in diabetes mellitus type 2 |
| 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 Swapnali Dattatray Talap |
| Designation |
PG scholar |
| Affiliation |
Late kedari redekar ayurvedic mahavidyalaya gadhinglaj kolhapur |
| Address |
A/P Bahadurwadi Tal Walwa Dist Sangli Maharashtra India
P 2 MIDC Area Shendri Road Mal Gadhinglaj Maharashtra 416501
Kolhapur
MAHARASHTRA
415411
India |
| Phone |
7083492777 |
| Fax |
|
| Email |
sdtalap123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satgonda B Patil |
| Designation |
Reader Kayachikitsa department |
| Affiliation |
Late kedari redekar ayurvedic mahavidyalaya P G training and research centre gadhinglaj kolhapur |
| Address |
OPD 1 Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital kayachikitsa OPD Gadhinglaj Kolhapur Pin
416502
OPD 1 Late kedari redekar ayurvedic mahavidyala and hospital Kayachikitsa OPD P 2 MIDC Area Shendri Road Mal Gadhinglaj Maharashtra 416501
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8600660485 |
| Fax |
|
| Email |
drjayantpatil07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnali Dattatray Talap |
| Designation |
PG scholar |
| Affiliation |
Late kedari redekar ayurvedic mahavidyalaya gadhinglaj kolhapur |
| Address |
A/P Bahadurwadi Tal Walwa Dist Sangli Maharashtra India
P 2 MIDC Area Shendri Road Mal Gadhinglaj Maharashtra 416501
Kolhapur
MAHARASHTRA
415411
India |
| Phone |
7083492777 |
| Fax |
|
| Email |
sdtalap123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD patients at Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur India Pin code -416502 |
|
|
Primary Sponsor
|
| Name |
Dr Swapnali Dattatray Talap |
| Address |
OPD 1 Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital Kayachikitsa department Gadhinglaj Kolhapur India Pin code -416502 |
| 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 |
| Dr Swapnali Dattatray Talap |
Late Kedari Redekar dharmaday rugnalayGadhinglaj Kolhapur |
Late Kedari Redekar Ayurvedic
Mahavidyalaya and hospital kayachikitsa department room no. 1 kayachikitsa OPD
Gadhinglaj Kolhapur Pin 416502
Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA |
7083492777
sdtalap123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
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: Gokshurguggulu vati, Reference: Gadanigraha Dvitiya Kayachikitsakhanda Pramehadhikar 30, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
History of Diabetes mellitus less than 3 years.
Patients presenting with Prakarsha mutrata(Increased frequency of
urination)Prabhut mutrata(polyuria)Aavila mutrata(Turbid urine).
Random blood sugar level should be below 300 mg/dl
fasting blood sugar level below 200 mg/dl
post prandial sugar level below 300 mg/dl |
|
| ExclusionCriteria |
| Details |
lusion criteria:-
1. Patients of Diabetes Mellitus Type-1
2. Patients having history of raised Blood Sugar Level more than 3 years .
2. Patients of Diabetes Mellitus Type-2 other than Hyperglycemia.
3. Patient will be excluded below age 39 years and above 71 years old.
4. Patient suffering from Chronic kidney disease, HIV, Tuberculosis,
Tumors.
5. Macrovascular (CAD,PVD,CVD) diseases.
6. Pregnancy induced diabetes mellitus
7. Patients having complications like Diabetic ketoacidosis, Retinopathy,
Neuropathy,Nephropathy, Gangrene, etc.
8. Juvenile Diabetes Mellitus, Diabetes insipidus.
9. Patients suffering from congenital, chronic systemic illness,
Chemotherapy and radiation therapy of CA patients.
10. Surgical and traumatically injured patients.
11. Congenital anomalies of pancreas. Patient who will discontinue the
treatment.
12. Patient unwilling to take the treatment during study.
13. Patient shows any type of adverse effect.
14. Patient who do not attend follow ups regularly. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gokshurguggulu vati is significantly
effective in Madhumeha |
Initial assessment at 0 day
Follow up 7th 14th 21st and 30th day
Final assessment at 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gokshurguggulu vati is not significantly effective
in Madhumeha As compared to tab Metformin 500 mg |
Initial assessment at 0 day
Follow up 7th 14th 21st and 30th day
Final assessment at 30th day |
|
|
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)
|
22/09/2025 |
| 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="6"
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
|
The study is a randomized controlled clinical trial to study efficacy of gokshurguggulu vati with tablet metformin in the management of madhumeha with special reference to hyperglycemia in diabetes mellitus type 2 . Study will be carried out at the OPD of kayachikitsa
department of Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital Gadhinglaj Kolhapur. The observation would be drawn on the basis of relief of symptoms after treatment given. |