| CTRI Number |
CTRI/2024/08/072386 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Clinical Study of Unani Formulations in the Management
of Abnormal Vaginal Discharge |
|
Scientific Title of Study
|
Comparative Clinical Study of Unani Formulations in the Management
of Bacterial Vaginosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rushda Fatma |
| 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
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
8887698311 |
| Fax |
|
| Email |
rushda0601@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 Ilmul Qabalat wa Amraze Niswan State Takmeel Uttib College and Hospital Lucknow Near Ramabai Raily Sthal Bijnor Road Aurangabad Tiraha Lucknow
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
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 Near Ramabai Raily Sthal Aurangabad Tiraha lucknow Uttar Pradesh India 226002 |
|
|
Primary Sponsor
|
| Name |
State Takmeel Uttib College And Hospital |
| Address |
Near Ramabai Raily Sthal Bijnor Road Aurangabad Tiraha Lucknow Uttar Pradesh India 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 Rushda Fatma |
State Takmeel Uttib College and Hospital |
OPD No 111 Department of Ilmul Qabalat wa Amraze Niswan
Lucknow
UTTAR PRADESH |
8887698311
rushda0601@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: N899||Noninflammatory disorder of vagina, unspecified, (2) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ma‘jūn Mochras
Mochras Firzaja |
Ma‘jūn Mochras 10gm orally with water in the morning daily and Mochras
Firzaja per vaginum daily at bedtime for the duration of 3 weeks |
| Comparator Agent |
Ma‘jūn Mochras |
Ma‘jūn Mochras 10gm orally with water in the morning daily for the duration of
3 weeks |
| Intervention |
MOCHRAS FIRZAJA |
Mochras Firzaja per vaginum daily at bedtime for the duration of 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married women above the age of 18 years with regular menstrual cycle
Complain of vaginal discharge associated with low backache lower abdominal pain
and vulvae itching
 Positive Amsel’s criteria |
|
| ExclusionCriteria |
| Details |
Pregnant, lactating and menopausal women
Women on antibiotics and hormones in present and recent past
Women with IUCDs
Women with other pelvic pathology STDs genital prolapse and unhealthy cervix
Women with known history of systemic and endocrinal diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical cure defined as resolution of subjective symptoms of vaginal discharge
backache lower abdominal pain and vulval itching assessed by VAS |
Baseline
1st Week
2nd Week
3rd Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Negative Whiff test Normalization of vaginal pH Negative saline mount and
decreased Clue cells |
Before Treatment
After Treatment |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/08/2024 |
| Date of Study Completion (India) |
24/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/10/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 to either of the three
test groups (n=25 in each groups) after taking their consent. In one group, Mochras Firzaja
per vaginum will be given daily at bedtime. In second group, Ma‘jūn Mochras 10gm will
be given orally with water for duration of 3 weeks. In third group, Ma‘jūn Mochras 10gm
orally with water will be given in the morning daily along with Mochras Firzaja per
vaginum daily at bedtime for the duration of 3 weeks. . Follow up will be done on weekly
basis during the treatment and post treatment follow ups fortnightly will be done after
completion of the treatment. Subjective parameters will be assessed on each visit while
objective parameters will be assessed before and after completion of the treatment. |