| CTRI Number |
CTRI/2026/04/109568 [Registered on: 28/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Dhanyak-Gokshura Ghrita in the Management of Burning Urination |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of dhanyak gokshura ghrita in the management of pittaja mutrakrichhra w.s.r. to sadaha mutrapravrutti |
| 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 Nisha Umaraoji Nigut |
| Designation |
PG Scholar |
| Affiliation |
Dr. G. D Pol, Foundation, YMT Ayurvedic Medical College And Hospital |
| Address |
Dr G D Pol Foundation, Ymt Ayurvedic Medical College And Hospital, 3rd Floor, Surgery Department, Sector- 4, Kharghar, Navi Mumbai
Dr G D Pol Foundation, Ymt Ayurvedic Medical College And Hospital, 3rd Floor, Surgery Department, Sector- 4, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9763194140 |
| Fax |
|
| Email |
nishanigut2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Yadav |
| Designation |
Professor |
| Affiliation |
Dr. G. D Pol, Foundation, YMT Ayurvedic Medical College And Hospital |
| Address |
Dr G D Pol Foundation, Ymt Ayurvedic Medical College And Hospital, 3rd Floor, Surgery Dept, Sector- 4, Kharghar, Navi Mumbai
Dr G D Pol Foundation, Ymt Ayurvedic Medical College And Hospital, 3rd Floor, Surgery Dept, Sector- 4, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9322456999 |
| Fax |
|
| Email |
drsanjeevyadav22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Umaraoji Nigut |
| Designation |
PG Scholar |
| Affiliation |
Dr. G. D Pol, Foundation, YMT Ayurvedic Medical College And Hospital |
| Address |
Dr G D Pol Foundation, Ymt Ayurvedic Medical College And Hospital, 3rd Floor, Surgery Dept, Sector- 4, Kharghar, Navi Mumbai
Dr G D Pol Foundation, Ymt Ayurvedic Medical College And Hospital, 3rd Floor, Surgery Dept, Sector- 4, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9763194140 |
| Fax |
|
| Email |
nishanigut2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol Foundation, Ymt Ayurvedic Medical College And Hospital, 3rd Floor, Surgery Dept, Sector- 4, Kharghar, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr. Nisha Umaraoji Nigut |
| Address |
Dr G D Pol Foundation, Ymt Ayurvedic Medical College And Hospital, 3rd Floor, Surgery Dept, Sector- 4, Kharghar, Navi Mumbai |
| 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 Nisha Umaraoji Nigut |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital |
Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital ,3rd Floor ,Shalya Tantra Department . Sector-4, Kharghar ,Navi Mumbai 410210
Raigarh
MAHARASHTRA |
9763194140
nishanigut2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr G D pol foundation YMT ayurvedic medical college and charitable hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhanayak Gokshura Ghrita, Reference: भावप्रकाशस्त्य मध्यखण्डे३६/४१, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Dihydrogen Sodium Citrate | Syp Dihydrogen Sodium Citrate will be given 20ml Orally twice a day for 7 Days with water |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical symptoms of Pittaja Mutrakrichhra with sadaha
mutrapravrutti.
Aged between 18 to 60 years.
|
|
| ExclusionCriteria |
| Details |
Renal diseases, obstructive uropathy, urolithiasis,urinary tract malignancies
that complicates UTI management.
Patient having any systemic disorder interfering with the treatment will be
excluded.
Any congenital abnormality of urinary tract.
Uncontrolled diabetes mellitus.
Patients currently on antibiotic treatment or other medications for UTI.
Immunocompromised patients, such as those with HIV or other chronic immunosuppressive conditions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Dhanayak Gokshura Ghrita in management of Pittaja
Mutrakrichhra w.s.r. to Sadaha Mutrapravrutti Burning Micturation |
0,3rd & 7th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the role of Dhanayak Gokshura Ghrita in Routine and microscopic urine
examination like pH of Urine, Pus cells,RBCs,Epithelial Cells. |
0,3rd & 7th Day |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
18/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/05/2026 |
| 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 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
|
The Present Study is a PG Thesis Topic
By PG Scholar Dr. Nisha Umaraoji Nigut Guide Dr. Sanjeev Yadav Title
A Controlled Clinical Study to Evaluate the Efficacy of Dhanayak Gokshura
Ghrita in the Management of Pittaja Mutrakrichhra W.S.R.to Sadaha
Mutrapravrutti. Study Design
According to the inclusion and exclusion criteria, a total of 62 patients will be selected and randomly divided into two groups.Group A (Intervention Group) 31 patients will be Treated with Dhanayak Gokshura Ghrita twice daily for 07 days Group B (Control Group)
31 patients will be Treated with Disodium Hydrogen Citrate Syrup twice daily for 07 days Duration of the Study
1 year and 6 months |