| CTRI Number |
CTRI/2025/01/079407 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [nyagrodhadi Ghanvati and Nyagrodhadi Suppository] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pharmaceutical, analytical and clinical study on two dosage forms of Nyagrodhadigana in leucorrhea |
|
Scientific Title of Study
|
Pharmaceutico-analytical and clinical study on two dosage forms of nyagrodhadi gana w.s.r. to Shwetapradara |
| 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 Pratibha Vyas |
| Designation |
MD scholar |
| Affiliation |
Pt. Khushilal Sharma government autonomous college and institute |
| Address |
department of rsasashastra and bhaishajya kalpana, Pt. Khushilal Sharma ayurveda college and institute, Science hills, Nehru nagar bypass, road, Bhopal, MP.
Bhopal
MADHYA PRADESH
462002
India |
| Phone |
7977919304 |
| Fax |
|
| Email |
drpratibhavyas18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R K Pati |
| Designation |
professor |
| Affiliation |
Pt. Khushilal Sharma government autonomous college and institute |
| Address |
Department of rsasashastra and bhaishajya kalpana, Pt. Khushilal Sharma ayurveda college and institute, Science hills, Nehru nagar bypass, road, Bhopal, MP.
Bhopal
MADHYA PRADESH
462002
India |
| Phone |
9425677682 |
| Fax |
|
| Email |
patirajkishore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R K Pati |
| Designation |
professor |
| Affiliation |
Pt. Khushilal Sharma government autonomous college and institute |
| Address |
Department of rsasashastra and bhaishajya kalpana, Pt. Khushilal Sharma ayurveda college and institute, Science hills, Nehru nagar bypass, road, Bhopal, MP.
Bhopal
MADHYA PRADESH
462002
India |
| Phone |
9425677682 |
| Fax |
|
| Email |
patirajkishore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khusilal Sharma government autonomous college and Institute, Bhopal, MP- 462002 |
|
|
Primary Sponsor
|
| Name |
Pt. Khushilal Sharma government autonomous college and Institute |
| Address |
Pt. Khusilal Sharma government autonomous college and Institute, Bhopal, MP- 462002 |
| 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 Pratibha Vyas |
Pt. khushilal sharma govt. (auto) college and institute, bhopal. |
stri evam prasuti tantra OPD, Pt. Khushilal Sharma govt. ayurvedic hospital, Science hills, Nehru nagar bypass road, Bhopal, MP- 462002
Bhopal
MADHYA PRADESH |
07977919304
drpratibhavyas18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt Khushilal Sharma Government Ayurveda Institute Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N739||Female pelvic inflammatory disease, 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: nyagrodhadi ghana suppository, Reference: sushrut samhita sutrasthan 38-48/49, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: follow up on 5th 10th 15th day | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: nyagrodhadi ghanvati, Reference: sushruta samhita sutra 38-48/49, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: water), Additional Information: follow up on 5th 10th 15th day |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient complaining of white discharge per vagina as a cardinal symptom.
Age group between 18 to 45 years.
|
|
| ExclusionCriteria |
| Details |
Female less than 18 years of age and more than 45 years
Unmarried girls
Menopausal women
Pregnant and lactating mother
Any other chronic illness like carcinoma of cervix, uterine fibroid, vaginal polyp, chronic pelvic inflammatory diseases, cervical erosion.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptoms wise assessment parameters are, White discharge (Shwetastrav), Valval itching (yonikandu), Foul smell (yoni daurgandhya), Vaginal pain (yoni vedna), Prushth vedna (back ache), Daurbalya (weakness), Adhodar vedna (lower abdominal pain), Yoni daha (burning sensation in vagina). |
every 5th day for 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the improvements in secondary symptoms of shwetpradara like yonikandu, yonidourgandhya, yonivedna, prushtha vedna, daurbalya, adhoudar vedna, Yonidaha etc. |
every 5th day for 15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 research investigates the pharmaceutico-analytical and clinical aspects of Nyagrodhadi Gana, an Ayurvedic formulation used to treat Shwetapradara (abnormal vaginal discharge). The study aims to compare the efficacy of two dosage forms of Nyagrodhadi Gana—Ghanavati (tablet) and vaginal suppository—in managing symptoms associated with this condition. It involves preparing the formulations, conducting rigorous analytical tests, and a clinical trial with 40 participants to assess treatment outcomes. The expected results will contribute to validating traditional Ayurvedic practices and may enhance treatment options for women experiencing Shwetapradara. Ultimately, the research seeks to establish a standardized protocol for Nyagrodhadi Gana’s application in contemporary gynecological healthcare. |