| CTRI Number |
CTRI/2025/12/098486 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on JIVANI Tablets in patients suffering from white discharge |
|
Scientific Title of Study
|
A Clinical Evaluation of Efficacy and Safety of JIVANI Tablets in
patients suffering from PID (Leucorrhoea) - An open label,
multicentric, interventional, prospective, clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIVANI/GYNOVEDA/PID/2025/1, Version 1.0, 13th Oct 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avinash Deore |
| Designation |
Ayurveda Consultant Physician |
| Affiliation |
Shree Sai Ayurvedic Panchakarma Rugnalaya |
| Address |
Shree Sai Ayurvedic Panchakarma Rugnalaya
Department of Medicine, OPD no.1, 2nd Floor,
Kohinoor Arcade, Bus Stop, Sector No. 24, Pradhikaran,
Nigadi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822634478 |
| Fax |
|
| Email |
dravinashdeore2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd, A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd, A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Gynoveda Femtech Pvt. Ltd
Access work Level-9, Eureka Tower,
A-Wing Mindspace-IT Park, Chincholi Bunder
Malad West, Mumbai,
Maharashtra 400064
|
|
|
Primary Sponsor
|
| Name |
Gynoveda Femtech Pvt. Ltd |
| Address |
Access work Level-9, Eureka Tower, A-Wing Mindspace-IT Park, Chincholi Bunder
Malad West, Mumbai,
Maharashtra 400064
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Archana Jadhav |
Ayurved Seva Sangh, Ayurved Mahavidyala |
Department of Prasuti Tantra Department, OPD No. 5, Ground Floor, Ganeshwadi, Nashik 422003
Nashik
MAHARASHTRA |
7775058616
archujadhav88@gmail.com |
| Dr Madhu M |
SDM College of Ayurveda and Hospital |
Dept. Prasuti Tantra & Stree Roga OPD No. 21, Ground Floor, Bangalore - Mangalore Hwy, Thanniruhalla, Hassan- 573201
Hassan
KARNATAKA |
8970167939
drmadhuayu@sdmcahhassan.org |
| Dr Avinash Deore |
Shree Sai Ayurvedic Panchakarma Rugnalaya |
Department of Medicine, OPD no.1, 2nd Floor, Kohinoor Arcade, Bus Stop, Sector No. 24, Pradhikaran, Nigadi, Pune -411044
Pune
MAHARASHTRA |
9822634478
dravinashdeore2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurveda Seva Sangh, Ayurveda Mahavidyalaya, Nashik |
Submittted/Under Review |
| Institutional Ethics Committee SDM College of Ayurveda & Hospital, Hassan |
Submittted/Under Review |
| Kusum Independent Ethics Committee, Hadapsar, Pune |
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 | Other than Classical | | (1) Medicine Name: JIVANI Tablets, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: 2 Tablets of JIVANI two times daily after meals with water for 120 days. | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Non-pregnant, non-breastfeeding females (married and non-married) presenting complaints of scanty (mild) to moderate grade vaginal white
discharge on non-period days (Scanty or mild: small quantity of discharge, 1to 2 days a week, does not require change of undergarments; Moderate: moderate discharge 3 to 4 days a week, requires change of undergarments once daily) for a duration of not more than 180 days
2. Ready to provide written informed consent before initiation of any study
procedures and be available for all study visits
(Note: Subjects having asymptomatic ovarian cysts, asymptomatic fibroids, irregular periods and PCOD will be included)
|
|
| ExclusionCriteria |
| Details |
1. Suffering from severe cases of bacterial vaginosis (Purulent discharge with fishy smell) as per Investigator’s opinion
2. Women who had used prescribed medications (oral or topical antibiotics including metronidazole, clindamycin, tinidazole etc. Anti-fungal drugs including clotrimazole and ketoconazole etc.) for vaginal complaints in the past 2 weeks.
3. Including, but not limited to, ongoing or active infection, active liver, kidney and autoimmune diseases
4. Subjects with uncontrolled diabetes, hypertension and thyroid disease
5. Subjects with hepatitis B, C and HIV Positive, sexually transmitted diseases and active urinary tract infection
6. Subjects with endometriosis and uterine polyps, uterine adenomyosis,
symptomatic fibroids, cervical erosion
7. Patients on Oral Contraceptive Pills for last one month
8. Patients with IUCD for last one month
9. History of significant per vaginal bleeding
10. Prolapsed uterus
11. Known case of malignancy in the internal genital parts and known case of any malignancy
12. Allergy to any constituent of JIVANI Tablet
13. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in symptoms associated with Leucorrhoea |
Baseline visit, Day 30, Day 60, Day 90 and Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in tubal blocks as assessed using Hysterosalpingography (HSG)
2. Change in vaginal discharge analysis
3. Requirement of rescue medications (use of antibiotics, anti-fungal drugs and other medications)
4. Change in dyspareunia
5. Ovulation tracking assessed using ovulation kit
6. Global assessment for overall change by subject and investigator
7. Tolerability of study medications as assessed by participants and investigator
8. Safety evaluation by assessing adverse events, clinical symptoms, signs, vitals and laboratory tests
|
Baseline visit, Day 30, Day 60, Day 90 and Day 120 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
17/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is an open label,
multicentric, interventional, prospective, clinical study to evaluate efficacy
and safety of JIVANI Tablets in patients suffering from PID (Leucorrhoea). The
study will be conducted at 10 to 12 centres in India. Subjects will be asked to
take 2 Tablets of JIVANI two times daily after meals with water for 120 days.
The primary objective of the study will be to assess changes in symptoms
associated with Leucorrhoea. The secondary objectives of the study will be to
assess change in tubal blocks as assessed using Hysterosalpingography (HSG),
change in vaginal discharge analysis, requirement of rescue medications (use of
antibiotics, anti-fungal drugs and other medications), change in dyspareunia,
ovulation tracking assessed using ovulation kit, global assessment for overall
change by subject and investigator, tolerability of study medications as
assessed by participants and investigator, and safety evaluation by assessing
adverse events, clinical symptoms, signs, vitals and laboratory tests on Baseline
visit, Day 30, Day 60, Day 90 and Day 120 |