| CTRI Number |
CTRI/2024/08/072270 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Per vaginal use of peel of pomegranate in uterovaginal prolapse |
|
Scientific Title of Study
|
Efficacy of Hamul of Post Anar Punica granatum Linn in Uterovaginal
Prolapse: A Randomized Controlled Trial. |
| 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 Nawazisha |
| Designation |
PG Scholar |
| Affiliation |
State Takmeel Uttib College and Hospital Lucknow |
| Address |
Department of Ilmul Qabalat Wa Amraze Niswan
State Takmeel Uttib College and Hospital
Lucknow
Near Ramabai Raily Sthal Bijnor Road Aurangabad Tiraha
Lucknow
226002
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9045731928 |
| Fax |
|
| Email |
nawazishaansari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mani Ram Singh |
| Designation |
Reader |
| Affiliation |
State Takmeel Uttib College and Hospital Lucknow |
| Address |
Department of Ilumul Qabalat Wa Amraze Niswan
State Takmeel Uttib College and Hospital
Lucknow
Near Ramabai Raily Sthal Bijnor Road Aurangabad Tiraha
Lucknow
226002
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8423307654 |
| Fax |
|
| Email |
dr_maniramsingh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mani Ram Singh |
| Designation |
Reader |
| Affiliation |
State Takmeel Uttib College and Hospital Lucknow |
| Address |
Department of Ilmul Qabalat Wa Amraze Niswan
State Takmeel Uttib College and Hospital
Lucknow
Near Ramabai Raily Sthal Bijnor Road Aurangabad Tiraha
Lucknow
226002
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8423307654 |
| Fax |
|
| Email |
dr_maniramsingh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel Uttib College and Hospital Lucknow Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
State Takmeel Uttib College and Hospital |
| Address |
Near Ramabai Raily Sthal Bijnor Road Aurangabad Tiraha
Lucknow Uttar Pradesh
226002 |
| Type of Sponsor |
Government medical college |
|
|
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 Nawazisha |
State Takmeel Uttib College and Hospital |
OPD No 111 Department Of Ilmul Qabalat Wa Amraz Niswan
Lucknow
UTTAR PRADESH |
9045731928
nawazishaansari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE STATE TAKMEEL UTTIB COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N814||Uterovaginal prolapse, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo
|
Sterilized gauze piece will be given for per vagina use daily at
bedtime for 45 days excluding the duration of menses |
| Intervention |
Post Anar (peel of Punica granatum Linn. fruits) |
Sterilized gauze piece will be soaked into the decoction of post Anar and
will be made dry then will be given for per vagina use daily at bedtime for 45 days
excluding the duration of menses |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Married females above 30 years with 1st and 2nd degree POP-Q
|
|
| ExclusionCriteria |
| Details |
Pregnant & Lactating women
Women with systemic illness and other endocrinal disorders
Women with pelvic pathologies and suspected malignancies
Women on hormonal therapies or IUCDs
Chronic inversion and congenital elongation of cervix
Women with 3rd and 4th degree of uterine prolapse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in PFDIQ-20 and PFIQ-7 score |
15th day
30th day
45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Pelvic floor muscle strength by Oxford grading
POP-Q
|
15th day
30th day
45th 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)
|
16/08/2024 |
| 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
|
Patients meeting all the inclusion criteria will be randomly allocated either to test (n=25)
or control group (n=25) after taking their consent. Patients will be blinded for the study.
The sterilized gauze piece will be soaked into the decoction of post Anar and will be
made dry then will be given for per vagina use daily at bedtime for 45 days excluding the
duration of menses. In the control group, sterilized gauze pieces will be given for per
vagina use daily at bedtime for same duration. Pelvic floor muscle exercises will be
advised in both the groups. Efficacy parameters will be assessed on each visit |