| CTRI Number |
CTRI/2025/06/088956 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
07/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Darvyadi Kashaya orally and Karanja Churna orally along with Karanja Ointment locally in the management of Kaphaj Yonivyapad |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Darvyadi Kashaya in the management of Kaphaj Yonivyapad |
| 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 Sayali Anil Tambade |
| Designation |
PG Scholar |
| Affiliation |
CSMSS Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 19 Prasuti Tantra And Streerog Department CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India
OPD No 19 Prasuti Tantra Streerog Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9923686462 |
| Fax |
|
| Email |
sayalitambade1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Anandrao Havale |
| Designation |
Associate Professor |
| Affiliation |
CSMSS Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 19 Prasuti Tantra And Streerog Department CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India
OPD No 19 Prasuti Tantra And Streerog Department CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9822538957 |
| Fax |
|
| Email |
amolhavale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayali Anil Tambade |
| Designation |
PG Scholar |
| Affiliation |
CSMSS Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 19 Prasuti Tantra And Streerog Department CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India
OPD No 19 Prasuti Tantra Streerog Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9923686462 |
| Fax |
|
| Email |
sayalitambade1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
C.S.M.S.S Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Type of Sponsor |
Private 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 Sayali Anil Tambade |
C.S.M.S.S.Ayurved Mhavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra |
OPD NO 19 Prasuti Tantra And Streerog Department C.S.M.S.S. Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA |
9923686462
sayalitambade1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N889||Noninflammatory disorder of cervixuteri, unspecified. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: Karanja Ointment , Reference: NA, Route: Vaginal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | - | | | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadi Kashaya , Reference: Sharangdhar Samhita Madhyam Khanda 2/110,111, Route: Oral, Dosage Form: Malahara/ Ointment/ Balm, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Madhu ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Married women between 21-40 yrs
2.Non pregnant patients
3.Patients diagnosed with Kaphaj Yonivyapad with clinical features of Yonikandu,pandu,picchil strav and Alpavedana |
|
| ExclusionCriteria |
| Details |
1.Unmarried
2.Antenatal and Postnatal patients
3.Veneral diseases , Diabetes
4.Suspected case of Ca Cervix
5.Patient with IUCD & on contraceptive pills
6.Pelvic Inflammatory Diseases [PID] |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Darvyadi Kashaya in the management of Kaphaj Yonivyapad |
Baseline - 4th,7th,15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study Kaphaj Yonivyapad as per Ayurvedic view
2.To study Leucorrhea & vaginal health according to modern view
3.Any adverse effect of Darvyadi Kashaya in the Kaphaj Yonivyapad will be noted
4.To compare efficacy of Darvyadi Kashaya orally & Karanja churna orally along with Karanja ointment locally in the management of Kaphaj Yonivyapad |
Baseline - 4th,7th,15th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/06/2025 |
| 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 Applicable |
| 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
|
A healthy women is a promise of healthy family.In different phases of a womans life from puberty to menopause the concept of healthy Yoni has been mentioned in Ayurveda as well as in modern.Due to change in lifestyle modern food habits junk foods etc she is unable to follow the rules of Rutucharya Rajaswala charya Sutika paricharya and Garbhini paricharya.She becomes more prone to various Yonirogas.In Ayurveda Women health care is related in seperate section where the term Yonivyapad includes majority of gynaecological disorders. 20 Yonirogas are described in Ayurveda samhitas by different Acharyas.Kaphaj Yonivyapad is one among them which have Hetus consumption of Guru and Abhishyandi aahar and producing agnimandya which in turn causes formation of Vikrut kapha. This Vikrut kapha reaches Yoni and causes Yonigat Shwet strav[White discharge] Yonikandu [Vulval itching] Pandu [ Pallor of vulva] as Pradhan lakshanas. Non pathogenic vaginal leucorrhea it is discharge originates in vagina itself as transudation through vaginal wall. According to Charak Samhita and other Ayurvedic texts management of Kaphaj Yonivyapad is advised with the use of Ruksha Ushna guna and Kashaya Rasa. The prevalence rate of leucorrhea was 28.9% in India. Which was found significantly in married women than unmarried women .The genital area of female mostly remains moist causing a media for growth of organism and producing infection.which can result into complications such as yonivrana krimi vandhyatva . As the Drug described [Darvyadi Kashaya] are all having those properties which are helpful in sampraptibhang of Kaphaj Yonivyapad . Study will be conducted on 100 diagnosed patients of Kaphaj Yonivyapad .Written consent will be taken .Initiak assessment will be done .Patient treated with interventional group Darvyadi Kashaya and Control group Karanj churn orally along with Karanj ointment locally .Observation and result will be noted .Discussion and conclusion will be drawn . |