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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R32||Unspecified urinary incontinence. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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.  

 
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