| CTRI Number |
CTRI/2025/08/093672 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To See The Effect Of Triphladi Kwath Vaginal Wash And Bruhtyadi Fumigation With Triphladi Kwath Vaginal Wash In The Management Of Kaphaja Yonivyapad wsr Vulvovaginal Candidiasis |
|
Scientific Title of Study
|
A Randomized Open Label Comparative Clinical Trial To Evaluvate The Efficacy Of Triphladi Kwath Yoni Prakshlana And Bruhtyadi Yoni Dhupan With Triphladi Kwath Yoni Prakshlana In The Management Of Kaphaja Yonivyapad W.S.R To Vulvovaginal Candidiasis |
| 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 Mamta Sankhla |
| Designation |
Pg Scholar Stree Roga Prasuti Tantra |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD No 15 Department Of Sree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9991813057 |
| Fax |
|
| Email |
mamtasankhla.m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Chairperson |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD No 15 Pg Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Room No 112 Pg Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Sankhla |
| Designation |
Pg Scholar Stree Roga Prasuti Tantra |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD No 15 Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9991813057 |
| Fax |
|
| Email |
mamtasankhla.m@ gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies And Research Sector 8 Umri Road Kurukshetra Haryana PIN 136118 |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research Kurukshetra Haryana |
| Address |
Sector 8 Umri Road Kurukshetra Haryana PIN 136118 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mamta Sankhla |
Institute For Ayurved Studies And Research |
OPD No 15 Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8
Kurukshetra
HARYANA |
9991813057
mamtasankhla.m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, (2) ICD-10 Condition: N738||Other specified female pelvic inflammatory diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Triphladi Kwath Yoni Prakshlana |
Procedure Triphladi Kwath Reference Charak Samhita Chikitsa Sthana Chapter 30 Shloka 82-83 Procedure Details 25 Patients Will be Treated with Yoni Prakshlana Approx 500 mL after Cessation Of Menses For 10 consecutive Days |
| Intervention |
Triphladi Kwath Yoni Prakshlana And Bruhtyadi Yoni Dhupan |
Procedure Triphladi Kwath Reference Charak Samhita Chikitsa Sthana Chapter 30 Shloka 82 83 Bruhtyadi Yoni Dhupan Reference Sushruta Samhita Uttar Tantra Chapter 38 Shloka 27 Procedure Details 25 Patients Will be Treated With Bruhtyadi Yoni Dhupan With The Help Of Instrument For Minimum 3 Minutes After Triphladi Kwath Yoni Prakshlana aproxx 500 mL After Cessation Of Menses For 10 Consecutive Days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient of age in between 21 years to 45 years of age
Patients willing to participate in the trial
Married women
Patient Associated symptoms with
Yoni srava vaginal discharge
Yoni kandu Itching
Alpa vedaana (inguinal pain and backache)
Patient diagnosis of vulvovaginal candidiasis |
|
| ExclusionCriteria |
| Details |
Patient not willing to participate in the trial
Unmarried women and pregnant women
Age less then 21 years and more then 45 years
Patient with known case of pelvic pathology
Known case of sexually transmitted diseases like VDRL HIV Gonorrhea
Diagnosed systemic illness like asthma, tuberculosis ,malignancy etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Patients showing Improvement In The Grade Of Wet Vaginal Smear |
Follow up will be done on 11 18 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction In Symptoms Of Yoni Saraf ( Vaginal discharge) Yoni Vedna Yoni Kandu (Itching) |
Follow up will be done on 11 18 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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
|
Abnormal Vaginal Discharge Defined As Any Deviation In Terms Of Frequency Duration Regularity Or Volume Of Discharge It Affects Women Physical Social Emotional Well Being While Conventional Treatment Offers Symptomatic Relief They Are Associated With Side Effects And May Not be Suitable For All Patients This Randomization Open Label Comparative Clinical Trial Is To Evaluate The Efficacy Of Triphladi Kwath Yoni Prakshlana And Bruhtyadi Yoni Dhupan With Triphladi Kwath Yoni Prakshlana The Study Involves 50 Participants Who Are Diagnosed With Vulvovaginal Candidiasis Based On Clinical Evaluation And Supporting Investigations Triphladi Kwath Known For Its anti fungal activity against Candida albicanas Triphladi Traditionally Recognised For Its Tridosha - Balancing And Bruhtyadi Yoni Dhupan known For Direct Antifungal Antibacterial and Anti Inflammatory Effects On Vaginal Mucosa Controlling Itching and Discharge And Promoting Mucosal Healing Ayurvedic Formulation For Managing Kaphaja Yonivyapda This Will be Administered For 10 Consecutive Days To Reduce Symptoms Such As Excessive Discharge And Other Symptoms Outcome Measure Will Include Both Subjective And Objective Parameters This Study Will Offer A Potentially Safer Alternative To Conventional Treatment |