| CTRI Number |
CTRI/2026/01/100340 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Nagkeshar yog and Fas kit in shwetpradar |
|
Scientific Title of Study
|
A randomized controlled clinical trial to assess the efficacy of Nagkeshar Yog in Shwetpradar with special reference to Leucorrhea. |
| 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 PRANALI SURESH BANGAR |
| Designation |
PG SCHOLAR |
| Affiliation |
DR G D Pol Foundation,YMT Ayurvedic Medical College and Hospital,Kharghar |
| Address |
DR G D Pol Foundation,YMT Ayurvedic Medical College and Hospital,3rd floor,Gynac department,Sector4,Kharghar Navi mumbai
DR G D Pol Foundation,YMT Ayurvedic Medical College and Hospital,3rd floor,Gynac department,Sector4,Kharghar Navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8169677988 |
| Fax |
|
| Email |
pranalibangar2505@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SEEMA MEHERE |
| Designation |
HOD & Associate Professer of PTSR |
| Affiliation |
DR G D Pol Foundation Ayurvedic Medical College and Hospital,Kharghar |
| Address |
DR G D Pol Foundation,YMT Ayurvedic Medical College and Hospital,3rd floor,Gynac department,Sector4,Kharghar Navi mumbai
DR G D Pol Foundation,YMT Ayurvedic Medical College and Hospital,3rd floor,Gynac department,Sector4,Kharghar Navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930940403 |
| Fax |
|
| Email |
seema.mehre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRANALI SURESH BANGAR |
| Designation |
PG SCHOLAR |
| Affiliation |
DR G D Pol Foundation Ayurvedic Medical College and Hospital, Kharghar |
| Address |
DR G D Pol Foundation,YMT Ayurvedic Medical College and Hospital,3rd floor,Gynac department,Sector4,Kharghar Navi mumbai
DR G D Pol Foundation,YMT Ayurvedic Medical College and Hospital,3rd floor,Gynac department,Sector4,Kharghar Navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8169677988 |
| Fax |
|
| Email |
pranalibangar2505@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol Foundation, YMT Ayurvedic Medical College and Hospital, sector 4, Kharghar, Navi Mumbai,Raigarh, Maharashtra, 410210 ,India |
|
|
Primary Sponsor
|
| Name |
Dr Pranali Suresh Bangar |
| Address |
Dr G D Pol Foundation, YMT Ayurvedic Medical College and Hospital,3rd floor,Gynac department,sector4,Kharghar, Navi Mumbai,Raigarh, Maharashtra 410210,India |
| 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 PRANALI SURESH BANGAR |
Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital |
3rd floor,Gynac department, Sector4 Kharghar,Navi mumbai,Raigarh,Maharashtra 410210,India
Raigarh
MAHARASHTRA |
8169677988
pranalibangar2505@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee Dr G D Pol Foundation YMT ayurvedic medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nagkeshar yog, Reference: Bhavprakash somrog adhay 69/11, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | TAB FAS 3 KIT | Flucopnazole 150mg
Azithromycin 1gm
Secnidazole 1gm |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Chronic Leucorrhea
2. Age group of 18-45 years
3.Willingness to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Known case of malignancy
2.Uncontrolled Diabetes Mellitus
3.Abnormal vaginal bleeding such as menorrhagia
4.Systemic diseases like severe anemia, severe PID and serological disorder like HIV , HbsAg,HCV, thyroid disorder etc.
5. Physiological white discharge |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Nagkehsar Yog in shwetpradar w.s.r. to Leucorrhea |
1st visit- day 0
2nd visit-day 7
3rd visit- day 14
4th visit-day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To put forth the effective, safe and less time consuming management of shwetpradar |
1st visit- day 0
2nd visit-day 7
3rd visit- day 14
4th visit-day 30 |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 1 |
|
Date of First Enrollment (India)
|
14/01/2026 |
| 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)
|
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 Present Study is a PG Thesis Topic By PG Scholar - DR PRANALI SURESH BANGAR and Guide Name-DR SEEMA MEHERE
Title- A RANDOMIZED CONTROLLED CLINICAL TRIAL TO ASSES THE EFFICACY OF NAGKESHAR YOG IN SHWETPRADAR WITH SPECIAL REFERENCE TO LEUCORRHEA.
According to inclusion and exclusion criteria Group A 38 patient and Group B 38 patient will be selected Group A ( intervention ) will be given nagkeshar yog 12gm with takra empty stomach OD for 3 days Group B ( control/comparative) will be given TAB FAS 3 KIT once a week
Total duration of study is 1 year 6 months. |