| CTRI Number |
CTRI/2025/05/086690 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Clinical Role of Panchawalkala Ghrita Yonipichu in Pittaja Yonivyapad |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL OF PANCHAWALKALA SIDDHA GHRITA YONIPICHU IN THE MANAGEMENT OF PITTAJA YONIVYAPAD |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrapali Bhimrao Bansod |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur |
| Address |
Department Of Stree Roga Evum Prasuti Tantra LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur Tal Walwa Dist Sangali
Department Of Stree Roga Evum Prasuti Tantra LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur Tal Walwa Dist Sangali
Sangli
MAHARASHTRA
415409
India |
| Phone |
8080563554 |
| Fax |
|
| Email |
amrapalibansod96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Jagannath Patil |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur |
| Address |
Department Of Stree Roga Evum Prasuti Tantra LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur Tal Walwa Dist Sangali
Department Of Stree Roga Evum Prasuti Tantra LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur Tal Walwa Dist Sangali
Sangli
MAHARASHTRA
415409
India |
| Phone |
9422407301 |
| Fax |
|
| Email |
SachinPatil5190@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrapali Bhimrao Bansod |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur |
| Address |
Department Of Stree Roga Evum Prasuti Tantra LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur Tal Walwa Dist Sangali
Department Of Stree Roga Evum Prasuti Tantra LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur Tal Walwa Dist Sangali
Sangli
MAHARASHTRA
415409
India |
| Phone |
8080563554 |
| Fax |
|
| Email |
amrapalibansod96@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of Stree Roga Evum Prasuti Tantra Department of LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur Tal Walwa Dist Sangali 415409 (Maharashtra) india |
|
|
Primary Sponsor
|
| Name |
DR AMRAPALI BHIMRAO BANSOD |
| Address |
Department Of Stree Roga Evum Prasuti Tantra LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur Tal Walwa Dist Sangali |
| 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 AMRAPALI BHIMRAO BANSOD |
LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur |
Department Of Stree Roga Evum Prasuti Tantra LRP Ayurvedic Medical College and Hospital and PG Institute and Research Centre Uran Islampur Tal Walwa Dist Sangali 415409 MAHARASHTRA
Sangli
MAHARASHTRA |
8080563554
amrapalibansod96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of the College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: Charak Samhita, Procedure details: Pichu is made up of cotton swab of size 2×3 cm (1 inch), wrapped with gauze piece &
tied with long thread. It immersed in panchawalkala siddha ghrita for trial group &
sariva siddha ghrita for control group.
These preparations have two main functions
Shodhana (purification) and Ropana (healing).
Duration:14 days after cessation of menses
Place: Pratham Avarta Yoni (Vaginal canal)
Pichu Dharana Kala: Aamutra Vega (Urge to urinate) )
(1) Medicine Name: Sariva siddha ghrita, Reference: Charak Samhita, Route: Vaginal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: Charak Samhita, Procedure details: Pichu is made up of cotton swab of size 2×3 cm (1 inch), wrapped with gauze piece & tied with long thread. It immersed in panchawalkala siddha ghrita for trial group & sariva siddha ghrita for control group. These preparations have two main functions Shodhana (purification) & Ropana (healing). Duration:14 days after cessation of menses Place: Pratham Avarta Yoni (Vaginal canal) Pichu Dharana Kala: Aamutra Vega (Urge to urinate))
(1) Medicine Name: panchawalkala siddha ghrita, Reference: Charak Samhita, Route: Vaginal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of pittaja yonivyapad
pelvic inflammatory disease
Married women
Non pregnant women |
|
| ExclusionCriteria |
| Details |
Unmarried women
Pregnant women
Patients with Uncontrolled Diabetes
Hypertension Asthma
Patients with malignancies
sexually transmitted disease
intrauterine
contraceptive device.
HIV
HBsAG
positive
Patients with exclusively vulvitis and bartholinitis
Patients not willing to give informed consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief form yonigatdaha and yonigat vedana |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief From Signs And Symptoms |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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)
|
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
|
Purpose Of The Study :- Investigating Pittaja Yonivyapada And Its Impact On Women’s Health And Treating Pittaja Yonivyapada Effectively Is Essential To Prevent The Long-Term Health Consequences Associated With This Disorder.
Aim :- The aim of this study is to investigate the etiology, symptoms, and management of pittaja yonivyapada, a condition primarily caused by the consumption of excessive katu, amla, lavana, and ksharadi pittavardhak aahara.
Objectives :-
The primary objective of this study is to investigate pittaja yonivyapada, its causes, symptoms, and implications for women’s fertility and overall health. Specifically, the study will explore the relationship between pitta imbalance and the development of various symptoms like burning sensations, inflammation, pain, and excessive vaginal discharge. Furthermore, the study will examine the importance of proper treatment to avoid potential complications such as infertility, abnormal uterine bleeding, and other reproductive disorders
Hopothesis:- 1. Null Hopothesis : Panchawalkala Siddha Ghrita Yonipichu Is Not Effective In The Management Of Pittaja Yonivyapada.
2. Alternate Hypothesis :
Panchawalkala Siddha Ghrita Yonipichu Is Effective In The Management Of Pittaja Yonivyapada.
Procedure: - ( Procedure For The Management Of Yonivyapada)
Approval from the institutional ethical committee (iec) will be taken before commencement of the study.
1. Diagnosis (Nidan) :
A thorough understanding of the patient’s symptoms and underlying causes is crucial. In ayurvedic practice, diagnosis is based on a detailed Evaluation Of The Patient’s History (Prakriti), Symptoms (Lakshana), And Dosha Involvement.
2.Diet And Lifestyle Modification (Aahar-Vihar) :
1. Foods To Avoid :- Katu (Spicy), Amla (Sour), Lavana (Salty), And Kshara (Alkaline) Foods As They Aggravate Pitta Dosha.Fried, Acidic, And Heavily Processed Foods.Excessive Consumption Of Alcohol And Stimulants Like Caffeine
2. Foods To Include :- Pitta-Pacifying Foods: Foods That Are Sweet, Bitter, And Astringent In Taste.Fresh Fruits Like Coconut, Melons, Cucumbers, And Pears.
Herbal Treatments And Remedies :Shatavari,Ashoka,Guduchi,Brahmi Etc.
3. Panchakarma (Detoxification) :-Virechana(Purgation),Basti (Enema),Abhyanga (Oil Massage),Shirodhara
4. Monitoring And Follow-Up
Rescue Medications Duly Prescribed By Physician Will Be Continued Along With The Physiotherapeutic Approach In Both The Groups During The Study.
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