| CTRI Number |
CTRI/2025/05/086482 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
a study to assess the effect of kapikacchu root decoction in improving vaginal tightness in women |
|
Scientific Title of Study
|
A clinical study to evaluate the yoni sankirnta effect of yoni pichu with kapikacchu moola kwatha w.s.r . To vaginal laxity |
| 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 KHUSHBU KAUSHIK |
| Designation |
PhD scholar |
| Affiliation |
FIMS, SGT university gurugram |
| Address |
FIMS, SGT UNIVERSITY, DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA ,GURUGRAM
Gurgaon HARYANA 122505 India |
| Phone |
9990460123 |
| Fax |
|
| Email |
khushsharma710@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr jyoti kumbar |
| Designation |
guide |
| Affiliation |
FIMS, SGT university gurugram |
| Address |
FIMS, SGT UNIVERSITY, DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA, GURUGRAM
Gurgaon HARYANA 122505 India |
| Phone |
09482628541 |
| Fax |
|
| Email |
drjyotik11@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr jyoti kumbar |
| Designation |
guide |
| Affiliation |
FIMS, SGT university gurugram |
| Address |
FIMS, SGT university , DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA, GURUGRAM
Gurgaon HARYANA 122505 India |
| Phone |
9482628541 |
| Fax |
|
| Email |
drjyotik11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Name -dr khushbu kaushik
Address- SGT, UNIVERSITY gurugram
type of support - self funded (monetary) with institutional material support( infrastructure and resources) |
|
|
Primary Sponsor
|
| Name |
Dr Khushbu kaushik |
| Address |
FIMS , SGT university , gurugram
122505 |
| 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 khushbu kaushik |
SGT Ayurveda Hospital |
FIMS, SGT UNIVERSITY , DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA Gurgaon HARYANA |
9990460123
khushsharma710@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FIMS, SGT UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R32||Unspecified urinary incontinence. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Yoni pichu | (Procedure Reference: Yogratnakar, Procedure details: Yoni pichu will be done for 35 days ) (1) Medicine Name: Kapikacchu moola kwatha, Reference: Yogratnakar , Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: od, Duration: 35 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients having 1 degree uterine prolapse with or without cystocele or rectocele, patients diagnosed with vaginal laxity on P/S or P/V examination, patients who is willing to take the treatment |
|
| ExclusionCriteria |
| Details |
unmarried, pregnant women, infections of vulva,vagina and uterus, acute UTI, psychologically unstable, any benign or malignant growth in genital tract, 2nd and 3rd degree uterine prolapse and PID, having hormonal disorder like PCOS and congenital abnormalities of genital tract. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in vaginal laxity, tissue integrity and tone |
0,3,5 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in vaginal health parameters,
quality of life, sexual function & satisfaction |
0,3,5 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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)
|
10/06/2025 |
| 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="2" 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
|
Yoni-Shaithilya is made up of two words Yoni and Shaithilya. The word Yoni in Ayurvedic classics is used to denote genital tract or perineum as a whole, uterus and vaginal canal. The word Shaithilya means looseness or laxity; the quality or state of being lax. Ancient Acharyas have mentioned 20 types of Yoni Vyapad which includes almost all types of gynaecological disorders, developing due to vitiation of vata, pitta and kapha. But Yoni Shaithilya is not described as a disease in Ayurvedic literature. It is mentioned as a symptom of various types of Yonivyapads i.e. Vatala, Mahayoni, Prasamsini, Andini/Phalini yonivyapad . Vaginal laxity is the looseness of the vagina usually caused by physiological changes in a woman’s life, such as childbirth, weight fluctuations, and hormonal changes due to aging and menopause. It damages the pelvic floor and devitalizes the mucosal tone of the vaginal wall. These events often lead to the development of vaginal atrophy, dryness, reduced sexual satisfaction thus causing physiological distress, and affecting a woman’s quality of life, self-confidence, and sexuality. Its incidence is about 24-38% . This happens mostly in multiparous and postmenopausal women. In ayurveda, many Sthanik chikitsa prescribed by ancient Acharyas such as Seka(vaginal douche), Abhyanga(massage) and Yoni pichu (vaginal tampon). Yoni pichu , a traditional ayurvedic practice, aims to address this issue and restore vaginal tone and elasticity. |