| CTRI Number |
CTRI/2025/03/081683 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vatadi Taila soft gel capsule and pichu in Shwetha Padara |
|
Scientific Title of Study
|
A Randomised Comparitive Clinical Study to Evaluate The Effect of Vatadi Taila Yoni Pichu and Vatadi Taila Vaginal Soft Gel Capsule In The Management Of shwetha Pradara |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D Divya |
| Designation |
PG scholar |
| Affiliation |
Shri Dharmasthala manjunatheswara ayurveda college and hospital Udupi |
| Address |
OPD number 1
Ground floor
Shri Dharmasthala manjunatheswara ayurvedic College hospital and research centre kuthpady Udupi Karnataka India
OPD number1
Ground floor
Shri Dharmasthala manjunatheswara ayurvedic College hospital and research centre kuthpady Udupi Karnataka India
Udupi
KARNATAKA
574118
India |
| Phone |
9113973311 |
| Fax |
|
| Email |
divyadhariwal90410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Suchethakumari |
| Designation |
Associate professor |
| Affiliation |
Shri Dharmasthala manjunatheswara ayurveda college and hospital Udupi |
| Address |
OPD number 1
Ground floor
Shri Dharmasthala manjunatheswara ayurvedic College hospital and research centre kuthpady Udupi Karnataka India
OPD number 1
Ground floor
Shri Dharmasthala manjunatheswara ayurvedic College hospital and research centre kuthpady Udupi Karnataka India
Udupi
KARNATAKA
574118
India |
| Phone |
94485 29574 |
| Fax |
|
| Email |
divyadhariwal90410@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Suchethakumari |
| Designation |
Associate professor |
| Affiliation |
Shri Dharmasthala manjunatheswara ayurveda college and hospital Udupi |
| Address |
Opd number 1
Ground floor
Shri Dharmasthala manjunatheswara ayurvedic College hospital and research centre kuthpady Udupi Karnataka India
Opd number 1
Ground floor
Shri Dharmasthala manjunatheswara ayurvedic College hospital and research centre kuthpady Udupi Karnataka India
Udupi
KARNATAKA
574118
India |
| Phone |
94485 29574 |
| Fax |
|
| Email |
divyadhariwal90410@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM HOSPITAL OF AYURVEDA UDUPI |
|
|
Primary Sponsor
|
| Name |
D Divya |
| Address |
Shri Dharmasthala manjunatheswara ayurvedic College hospital and research centre kuthpady Udupi Karnataka India 574118 |
| 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 D DIVYA |
SDM COLLEGE AND RESEARCH CENTRE KUTHPADY UDUPI 574118 |
Opd and Ipd of department of prasuti tantra and stree roga
SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI 574118
Udupi
KARNATAKA |
9113973311
divyadhariwal90410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE HUMAN SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA UDUPI |
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 | Other than Classical | | (1) Medicine Name: Vatadi taila , Reference: NA, Route: Vaginal, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Vatadi taila , Reference: NA, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: GIVEN IN THE FORM OF YONI PICHU |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of Shwetha pradara
Patient fulfilling diagnostic criteria Patients aged between 18-50years
Married women |
|
| ExclusionCriteria |
| Details |
During the menstrual phase of patient Diagnosed with Sexually transmitted diseases
Patient using Intrauterine contraceptive diseases
Subjects positive for HIV HBsAG VDRL |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare Effect Of Vatadi Taila Vaginal Soft Gel Capsules And Vatadi Taila Yoni Pichu In Swetha pradara |
Yoni srava ,Yoni kandu ,Yoni Vedana Yoni daurgandha ,Quantity of Vaginal Discharge And Vaginal pH will be assessed before Treatment and at a duration of seventh day, fourteenth day and after one month from the start of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare Effect Of Vatadi Taila Vaginal Soft Gel Capsules -3 capsule of 1 ml each BD Dose for 7 days And Vatadi Taila Yoni Pichu-10ml for days OD dose for 7 days In Swetha pradara |
Yoni srava ,Yoni kandu ,Yoni Vedana Yoni daurgandha ,Quantity of Vaginal Discharge And Vaginal pH will be assessed before Treatment & at duration of seventh day , fourteenth day & after one month of starting of study .Follow up 1 after 1 week & Follow up 2 after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
15/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/05/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Vaginal discharge emerges as a delicate yet vital aspect of female reproductive health embodies a spectrum ranging from the physiological to the pathological Normally vaginal discharge happens in regular variations in amount and consistency during the course of the menstrual cycle Physiological excess of vaginal discharge may not require specific treatment However pathological conditions involving infections like Candida Trichomonas and gram negative gram positive bacteria may necessitate its management Pathological discharge may also result due to noninfective diseases such as genital tract tumours or fistula and chemical vaginitis as a result of the use of perfumed soaps, bath additives spermicides or foreign bodies in vagina Chakrapanidatta the commentator of Charaka Samhita has explained Shwetapradara as Pandura Pradara and Indu the commentator of Ashtanga Sangraha explains it as Shukla Asrigdhara There is a mentioning of Shwetapradara in the later text books of Ayurveda like Sharangadhara Samhita Bhava Prakasha Yoga Ratnakara In the context of Yoni Srava Different varieties of vaginal discharges are explained under different context of Pradara like Tanu Shwetha Sakapha Picchila Snigdha Vidagdha Durgandhi Anyhow in all these references it has not been explained as a separate disease entity but as a symptom of an underlying pathology Although Shweta Pradara seeks maximum attention from the physicians irrespective of the underlying pathology there is no reference for the terminology Shweta Pradara in the Brihatrayee Though Kapha and Vata seem to be leading Doshas responsible for Shwetapradara the role of Pitta cannot totally be neglected here as it is said to be responsible for Paka So Shwetapradara can be considered a Vata Kapha Pradhana Tridoshaja Vyadhi 8 Acharya has mentioned Chikitsa in two parts Abhyantara Chikitsa and Sthanika Chikitsa Sthanika Chikitsa is beneficial when Sthanika Dosha Dusti is more and it gives strength to respective Sthana These local therapies have proved greatly beneficial in Stree Rogas if performed accurately Among which Yoni Pichu is also used widely in practice and has promising effects Yoni Pichu is tampon made up of cotton swab wrapped with gauze piece and tied with long thread medicated with taila, ghritha Kashaya etc which has to be placed by physician and should be removed at Amurta vegakala which sometimes may not be convenient or may be embarrassing on patient part In todays scenario with the help of advanced technology various intravaginal administration measures are available in the form of Vaginal soft gel capsule vaginal suppositories vaginal dispersable tablet and so on The yoni pichu can be tried in a modified form of vaginal soft gel capsule Which would be of self-administrative nature, cost effective could be inserted at home by patient herself without any assistance, which saves a lot of time The softgel vaginal insert was designed with mucoadhesive properties to facilitate retention of the product in the vagina and availability of the active ingredient in a site specific manner The drugs which are taken in this study are Vata Udumbara Yasthimadhu Lodhra Nimba these are being used in previous study in the form of Kashaya Prakshalana Pichu individually or in combination Hence they are collectively taken in the form of taila and incorporated in softgel capsule to see the effectiveness in Shwetapradara |