| CTRI Number |
CTRI/2026/04/108408 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
14/04/2026 |
| 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
|
A Clinical Study to reverse uterine prolapse with medicated tampons |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate the effect of Chavyadi Ghrita Yoni Pichu in Prasramsini Yonivyapad (Pelvic organ Prolapse) |
| 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 Alfiya Patel |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room number 13,Department of Prasuti Tantra and Stree Roga, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7879283571 |
| Fax |
|
| Email |
alfiyapatel099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkata Rathnakar |
| Designation |
HOD and Professor, Department of Prasuti Tantra and Stree Roga. |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room number 13,Department of Prasuti Tantra Evum Stree Roga,OPD Block Sri Jayandra Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai, Tamil NADU.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9840340826 |
| Fax |
|
| Email |
drlrathnakar@sjsach.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alfiya Patel |
| Designation |
PG Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 13,Department of Prasuti tantra Evum Stri Roga,Sri Jayandra Saraswathi Ayurveda College and Hospital,Nazarathpet, Chennai, Tamil NADU.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7879283571 |
| Fax |
|
| Email |
alfiyapatel099@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Alfiya Patel |
| Address |
PG Department of Prasuti tantra and Stri roga , Sri Jayendra Saraswathi Ayurveda College and Hospital |
| 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 Alfiya Patel |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu |
Department of Prasuti tantra and stri roga, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU |
7879283571
alfiyapatel099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Jayendra Saraswathi Ayurveda College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N819||Female genital prolapse, unspecified. Ayurveda Condition: PRASRAMSINI/PRASRAVINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: sushruta samhita uttartantra, Procedure details: Pre-Procedure (Purva Karma) –
Patient is asked to empty the bladder.
Patient is placed in supine position with flexed knees.
Treating doctor wears sterile gloves.
Yoni Abhyanga with Go-Ghrita in circular motion.
Swedana using Pichu dipped in warm distilled water.
Medicated Ghrita pre-heated by double boiling method.
B) Main Procedure (Pradhana Karma) – ~5 minutes insertion
Sterile Pichu soaked in Chavyadi Ghrita inserted into vagina using index finger.
Inserted till Pratham Avarta of Yoni (tip of finger depth).
Tail of Pichu kept outside vagina for easy removal.
Pichu retained for 2 hours (Amutrakala).
Patient advised to lie down during retention period.
C) Post-Procedure (Paschat Karma) –
After 2 hour/till urge of urination, Pichu is removed under aseptic precautions.
Study Duration
Treatment Period: 7 days (daily procedure)
Assessment: Day 0 and Day 7
Follow-up: After 1 month)
(1) Medicine Name: Chavyadi ghrita, Reference: 9. Rao GP. Ghrita Yoga Prakaranam. In: Sahasrayoga. New Delhi: Chaukhambha Publications; p. 585., Route: Vaginal, Dosage Form: Ghrita, Dose: 50(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Married women of age 35-60 years
Uterine prolapse 1st and 2nd degree
Rectocele mild to moderate
Cystocele mild to moderate |
|
| ExclusionCriteria |
| Details |
3rd degree uterine prolapse
procidentia
prolapse associated with decubitus ulcer
pregnant women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study assess the effect of Chavyadi ghrita Yoni Pichu in the management of first degree and second- degree pelvic organ prolapse.
To compare the effect of Chavyadi ghrita Yoni Pichu and Changeryadi ghrita Yoni Pichu in management of pelvic organ prolapse. |
0th day,7th day,30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of chavyadi ghrita yoni pichu in pelvic organ prolapse and subjective parameters.
Measuring anatomical repositioning or stabilization of prolapsed organs using clinical grading systems(e.g.POP-Q). |
|
|
|
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)
|
02/05/2026 |
| 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
|
Women’s health plays a vital role in the well-being of the family, society, and culture. Physical or mental disorders in women can significantly affect their educational, social, professional, and economic life. In modern times, stressful lifestyles, unhealthy food habits, and suppression of natural urges such as urination and defecation contribute to disturbances in the uterine environment, leading to a higher incidence of pelvic organ prolapse. This condition is commonly seen in gynecological practice, especially among parous women, due to weakness of pelvic structural support. Common symptoms include mass per vagina, urinary incontinence, overactive bladder, and fecal incontinence. According to WHO, the global prevalence of pelvic organ prolapse ranges from 2–20%, with a higher likelihood of hysterectomy in older women. It is classified based on the affected compartment: cystocele (anterior vaginal wall prolapse), rectocele (posterior vaginal wall prolapse), and vaginal vault prolapse (descent of the uterus, cervix, or vaginal apex). In Ayurveda, Yonivyapad occurs mainly due to the involvement of Vata Dosha, and treatment focuses on Vata-shamana, Brihana, Sandhana, Balya, and strengthening of pelvic floor muscles. Prasramsini Yonivyapad, described by Acharya Sushruta, can be correlated with uterine prolapse. Among Sthanika Chikitsa, Yoni Pichu is considered effective because the vaginal wall is highly vascular and allows better drug absorption, while its anatomical position helps retain medication longer; therefore, Yoni Pichu with Chavyadi Ghrita is chosen for study due to its easy availability, simple preparation, and cost-effectiveness. |