| CTRI Number |
CTRI/2024/12/078345 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Palashadi Kwatha and Darvyadi Kwatha on shwetpradara |
|
Scientific Title of Study
|
A Randomized comparative clinical study to evaluate the efficacy of Palashadi Kwath and Darvyadi Kwath in the management of Swetapradara 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 |
Komal Ravindra Nikam |
| Designation |
Post graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion near sion railway station Sion Mumbai 400022 |
| Address |
APMs Ayurved Mahavidyalaya Sion near sion railway station Sion Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9623426700 |
| Fax |
|
| Email |
komalrni25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Gopal Lamture |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station sion Mumbai 400022 Prasuti Tantra Evum Stree Rog Department. OPD No-8
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9819865834 |
| Fax |
|
| Email |
drplamture@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Gopal Lamture |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station sion Mumbai 400022.Prasuti Tantra Evum Stree Rog Department. OPD No-8.
MAHARASHTRA
400022
India |
| Phone |
9819865834 |
| Fax |
|
| Email |
drplamture@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurved Mahavidyalaya Sion |
|
|
Primary Sponsor
|
| Name |
Komal Ravindra Nikam |
| Address |
APMs Ayurved Mahavidyala sion near sion railway station sion Mumbai 400022
Mumbai
Maharashtra
400022
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 Komal Ravindra Nikam |
APMs Ayurved Mahavidyalaya Seth R V Ayurved Hospital Sion Mumbai |
APMs Ayurved Mahavidyala and Seth R V Ayurved Hospital sion near sion railway station sion Mumbai 400022
Mumbai
Maharashtra
400022
India
Mumbai
MAHARASHTRA |
9623426700
komalrni25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Palashadi Kwatha, Reference: BHARATBHAISHAJYA RATNAVALI ADHYAY 56 STREEROGADHIKAR KASHAYPRAKARANA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Darvyadi Kwatha, Reference: BHARATBHAISHAJYA RATNAVALI ADHYAY 56 STREEROGADHIKAR KASHAYPRAKARANA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age 18-40 years women
Patients with chief complaints of Shwetapradara
Patient having Kaphaj Yonivyapada in which Shweta Strava through vagina is main complaint
Voluntary willing patients with informed written concent
Patient irrespective of religion cast parity and occupation socioeconomic status
|
|
| ExclusionCriteria |
| Details |
Patient with Tubo ovarian mass
Patient with surgical intervention such as Cervical polyp 3rd degree Uterine prolapse
Patient suffering from HIV STD Hepatitis B
Pregnant patients
Patients diagnosed with malignancies of Genital track |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the symptoms of Shwetapradara |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Yonigat Shweta strav pramana, strav gandha, sthanik kandu and katishoola |
14 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="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
|
In ancient Ayurvedic text all gynecological disease come under the heading of Yonivyapadas.
For abnormal white vaginal discharge the word Shwetapradara has been described in Ayurvedic text like Sharangadhara Samhita, Bhavaprakasha , Yoga Ratnakara and in commentary of Charak Samhita by Chakrapani
Shwetapradara is a condition characterized by white vaginal discharge in excess amount. It is described as symptom in many Yonivyapadas as Kaphaja Yonivyapada, Acharna Yonivyapada, Upapluta Yonivyapada.
Leucorrhea also known as vaginal discharge is a very common condition that has been experienced by most women of all age group at some time or other.
It is defined as whitish or yellowish discharge of mucus from vagina. There are two types of Leucorrhea physiological and pathological.
Physiological Leucorrhea is mainly due to estrogen stimulation.
There are many causes of pathological vaginal discharge which include hormone imbalance, poor nutrition, improper hygienic conditions, sexually transmitted disease, use of contraceptives, bacterial fungal infection.
Kapha is the main causative factor for the vaginal discharge. In order to treat the Kapha Nidan parivarjana, Kaphanashak chikitasa and drug having properties of Katu, Tikta, Kashay can be use.
Previously done work to treat Shwetapradara has many sthanik chikitsa as Yonidhavana, Yonipichu etc. But for complete eradication of Shwetapradara abhyantara yogas can be more effective.
For this Palashadi kwatha with Madhu will be used to treat Shwetapradara. |