| CTRI Number |
CTRI/2024/10/076095 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate effect of Kakajanghadi Ghanvati orally and Triphladi Kwath Yoniprakshalana in the treatment of Kaphaja Yonivyapad (VULVOVAGINAL CANDIDIASIS) |
|
Scientific Title of Study
|
Clinical Study of Kakajanghadi Ghanvati Orally and Triphladi Kwath Yoniprakshalana In The Management of Kaphaja Yonivyapad (Vulvovaginal Candidiasis) |
| 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 Gayatri Butolia |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved,DSRRAU Jodhpur Jodhpur |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate
Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8306029511 |
| Fax |
|
| Email |
butoliagayatri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Sharma |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurved,DSRRAU Jodhpur |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate
Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9782371381 |
| Fax |
|
| Email |
vd_rashmi11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Butolia |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved,DSRRAU Jodhpur |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate
Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8306029511 |
| Fax |
|
| Email |
butoliagayatri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduation institute of Ayurved DSRRAU Jodhpur Rajasthan India 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduation institute of Ayurved DSRRAU Jodhpur Rajasthan |
| Address |
PG Department of Prasuti Tantra evam Stree Roga Post Graduate
Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan
Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN
342037 India |
| Type of Sponsor |
Government 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 Gayatri butolia |
Post Graduate institute of Ayurved, Jodhpur, Rajasthan |
P.G Department of
Prasuti Tantra evam
Stri Roga(OPD no-5),
Post Graduate Institute
of Ayurved, Dr.
Sarvepalli
Radhakrishnan
Rajasthan Ayurved
University, Nagaur
Road, Karwad,
Jodhpur, Rajasthan
342037 India Jodhpur
RAJASTHAN Jodhpur
Jodhpur
RAJASTHAN |
8306029511
butoliagayatri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Post graduate instiute of Ayurveda, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: charak chiktsa 30/83, Procedure details: Yoniprakshalana
1Litter once in a
day.[In the
morning.]
Duration For two months After cessation of
menses for 7 days
for two consecutive
cycles
)
(1) Medicine Name: Kakajanghadi Ghanvati, Reference: Yogratnakar pardar chikitsa18, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Woman after consummation of marriage.
➢ Patients fulfilling the diagnostic criteria.
➢ Patient willing to go through trial .
➢ Age between 18 years to 45years.
Patients complaining of :
1. Yoni Srava (Vaginal discharge).
2. Yoni Kandu (Itching).
3. AlpaVedana (Inguinal pain and backache).
4. Atisheetataa (Coldness) |
|
| ExclusionCriteria |
| Details |
Unmarried woman.
Pregnant women.
Age below 18years and after Menopause(45years)
Patients suffering from Pelvic Endometritis, Acute Appendicitis, Acute Salpingitis etc.
Second & third degree Uterine prolapse
Other Systemic illness like Bronchial asthma, Tuberculosis, Diabetes Mellitus, Malignancy
Hypertension, TORCH etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To reduce Yoni Srava (Abnormal Vaginal
Discharge), Kandu (Itching),
Vedana (Pain) |
60days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in associate features like (1)Picchila Yoni (Stickiness)
(2)Atisheetataa (Coldness)
(3)Paanduvarna (Colour of Vaginal Mucosa)
(4)Paandu Picchila Artava Srava (Colour &
consistency of menstrual blood |
60days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/12/2024 |
| 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 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
|
This is single group clinical study, open label to evaluate the effect of Kakajanghadi Ghanvati and Triphladi kwath in the management of Kaphaja Yoni Vyapad. The primary outcome to reduce Yoni Srava Yoni Srava (Abnormal Vaginal Discharge) Kandu (Itching), Vedana (Pain) with relief in associated features will be measured by subjective and objective parameters in that pap smear for cytology and inflammation study and cervical wet smear with gram staining for infection study. Kakajanghadi Ghanvati and Triphladi kwath act as anti inflammatory, anti microbial and reduce discharge so that could be use as preventive measure for reproductive tract infections. |