| CTRI Number |
CTRI/2025/08/093125 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A CLINICAL STUDY TO ASSESS THE EFFECT OF TRIVRIT TAILA PICHUU AND LAJJALU TAILA PICHUU IN THE MANAGEMENT OF UTERINE PROLAPSE |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABEL COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF TRIVRIT TAILA PICHUU AND LAJJALU TAILA PICHUU IN THE MANAGEMENT OF PRASRAMSINI YONIVYAPAD W.S.R 1ST AND 2ND DEGREE UTERINE 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 NISHU NARWAL |
| Designation |
MS SCHOLAR STREE ROGA PRASUTI TANTRA DEPARTMENT |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
OPD NO 15 DEPARTMENT OF STREE ROGA PRRASUTI TANTRA INSTITUTE FOR AYURVED STUDIES AND RESEARCH UMRI ROAD SECTOR 8 KURUKSHETRA HARYANA
Kurukshetra
HARYANA
136118
India |
| Phone |
9518193466 |
| Fax |
|
| Email |
nishunarwal40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNITI TANWAR |
| Designation |
PROFESSOR DEPARTMENT OF STREE ROGA PRASUTI TANTRA |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
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 |
9996311778 |
| Fax |
|
| Email |
drsunititanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NISHU NARWAL |
| Designation |
MS 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 |
9518193466 |
| Fax |
|
| Email |
nishunarwal40@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE FOR AYURVED STUDIES AND RESEARCH UMRI ROAD SECTOR 8 KURUKSHETRA HARYANA 136118 |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
UMRI ROAD SECTOR 8 KURUKSHETRA HARYANA 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 NISHU NARWAL |
INSTITUE FOR AYURVED STUDIES AND RESEARCH SECTOR 8 KURUKSHETRA HARYANA |
ROOM NO 112 STREE ROGA PRASUTI TANTRA DEPARTMENT UMRI ROAD SECTOR 8 KURUKSHETRA HARYANA 136118
Kurukshetra
HARYANA |
9518193466
nishunarwal40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAU IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N814||Uterovaginal prolapse, unspecified. Ayurveda Condition: PRASRAMSINI/PRASRAVINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | picu, पिचु | (Procedure Reference: SUSHRUT SAMHITA UTTARTANTRA 38, Procedure details: 25 PATIENTS WILL BE TREATED WITH TRIVRIT TAILA PICHUU AFTER CESSATION OF MENSES FOR 7 DAYS FOR 3 CONSECUTIVE CYCLE PICHUU IS RETAINED UNTIL NEXT URINATION OR FOR TWO HOURS)
(1) Medicine Name: TRIVRIT TAILA, Reference: CHARAK SAMHITA CHIKITSASTHAN CHAPTER 30, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | picu, पिचु | (Procedure Reference: SUSHRUT SAMHITA UTTARTANTRA 38, Procedure details: 25 PATIENT WILL BE TREATED WITH SOAKED PICHUU IN LAJJALU TAILA AFTER CESSATION OF MENSES FOR 7 DAYS FOR 3 CONSECUTIVE CYCLE PICHUU IS RETAINED FOR TWO HOURS OR UNTIL NEXT URINATION)
(1) Medicine Name: LAJJALU TAILA, Reference: BHAVPRAKASH PURVKHAND GUDUCHYADI VARG, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
PATIENTS HAVING AGE GROUP FROM 30 TO 55 YEARS
PATIENTS HAVING FIRST AND SECOND DEGREE UTERINE PROLAPSE
PATIENTS HAVING FIRST DEGREE UTERINE PROLAPSE WITH CYSTOCELE OR RECTOCELE
PATIENTS HAVING CLINICAL SIGN AND SYMPTOMS OF UTERINE PROLAPSE
PATIENTS WILLING TO PARTICIPATE IN TRIAL |
|
| ExclusionCriteria |
| Details |
PATIENTS BELOW AGE OF 30 YEARS AND ABOVE AGE OF 55 YEARS
PATIENTS HAVING THIRD DEGREE UTERINE PROLAPSE
PREGNANCY CASES
PATIENT HAVING CERVIX AND UTERINE MALIGNANCY
PATIENTS HAVING PROCIDENTIA WITH DECUBITUS ULCER OR VAULT PROLAPSE
PATIENTS WITH CONGENITAL PROLAPSE OR ELONGATION OF CERVIX
PATIENTS HAVING RECTAL PROLAPSE OR PELVIC INFLAMMATORY DISEASE
PATIENT PRESENTED WITH KNOWN CASE OF SEXUALLY TRANSMITTED DISEASE
FIBROID POLYP |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN QUANTITATIVE GRADING OF POP FOR UTERINE PROLAPSE |
FOLLOW UP WILL BE DONE ON 30TH 60TH 90TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN SIGN AND SYMPTOMS AND CHANGES IN ASSOCIATED CLINICAL FEATURES RELATED TO UTERINE PROLAPSE |
FOLLOW UP WILL BE DONE ON 8TH 14TH 30TH 38TH 44TH 60TH 68TH 74TH 90TH DAY |
|
|
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)
|
15/12/2025 |
| 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
|
PRASRAMSINI YONIVYAPAD IS ONE OF PITTAJ YONIVYAPAD AS DESCRIBED BY ACHARYA SUSHRUT WHICH IS CLINICALLY CORRELATED TO FIRST AND SECOND DEGREE UTERINE PROLAPSE IT IS THE HERNIATION OF UTERUS INTO OR BEYOND THE VAGINA DUE TO FAILURE OF LIGAMENTOUS AND FASCIAL SUPPPORT WHO ESTIMATE THE GLOBAL PREVELANCE RATE 2 TO 20 PERCENT OF UTERINE PROLAPSE AS PRASRAMSINI YONIVYAPAD IS A VATA ASSOCIATED PITTAJ YONIVYAPAD SO THIS STUDY AIMS TO EVALUATE THE EFFICACY OF TRIVRIT TAILA AND LAJJALU TAILA PICHUU AS BOTH DRUGS ARE PITTAHAR IN NATURE AND TAILA IS ONE OF BEST SNEHA FOR VATA IMBALANCE AND STHANIK CHIKITSA GIVES STRENGTH TO THE TISSUE REMOVING LAXITY WHICH IS BASIC DEFECT IN THIS YONIVYAPAD SO IN FORM OF PICHUU COORECTING IMBALANCE OF DOSHA AND IMPROVING QUALITY OF LIFE WITH COST EFFECTIVE AND CONSERVATIVE METHOD 25 PATIENT ASSIGNED IN EACH INTERVENTION ARM AND ASSESSMENT WILL NE DONE ON BASIS OF QUANTITATIVE GRADING OF POP AND CONCLUSION WILL BE DRAWN FROM STATISTICAL METHOD |