| CTRI Number |
CTRI/2025/10/096359 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the effect of oral satavar and vaginal pessary of camphor and Rogan e gul in the management of vaginal dryness: A pilot study |
|
Scientific Title of Study
|
A pilot study on the efficacy of oral satavar and vaginal pessary of camphor and Rogan e gul in the management of Vaginal dryness |
| 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 Amreen Begum |
| Designation |
Assistant professor |
| Affiliation |
Government nizamia tibbi college and general hospital |
| Address |
OPD room no 8 pg department of obstetrics and gynaecology government nizamia tibbi college and general hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9032024137 |
| Fax |
|
| Email |
dr.amreensiddiqui@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syeda Abidunnisa |
| Designation |
Pg professor |
| Affiliation |
Government nizamia tibbi college and general hospital |
| Address |
OPD room no 8 pg department of obstetrics and gynaecology government nizamia tibbi college and general hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9492027082 |
| Fax |
|
| Email |
syedaabudunnisa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amreen Begum |
| Designation |
Assistant professor |
| Affiliation |
Government nizamia tibbi college and general hospital |
| Address |
OPD room no 8 pg department of obstetrics and gynaecology government nizamia tibbi college and general hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9032024137 |
| Fax |
|
| Email |
dr.amreensiddiqui@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government nizamia tibbi college and general hospital charminar Hyderabad Telangana 500002 india |
|
|
Primary Sponsor
|
| Name |
Government nizamia tibbi college |
| Address |
Government nizamia tibbi college charminar Hyderabad Telangana |
| 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 Amreen Begum |
Government nizamia tibbi college |
OPD room no 8 pg department of obstetrics and gynaecology government nizamia tibbi college and general hospital charminar Hyderabad Telangana
Hyderabad
TELANGANA |
9032024137
dr.amreensiddiqui@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government nizamia tibbi college institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N952||Postmenopausal atrophic vaginitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.oral satavar
2. Vaginal pessary of Rogan e gul and camphor |
1. Patient will be given 6gm of above mentioned drug powder per day for 90 days
2. Patient will be given vaginal pessary of above mentioned drug per day for 10 days for 3 consecutive months |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Presence of at least one symptoms such as itching burning discomfort or pain during intercourse for at least past 3 months
2. Menopausal status:
a.postmenopausal woman (greater than 12 months since last menstrual period)
3.no use systemic or local estrogen therapy hormonal contraceptive or vaginal lubricant for at least 2 weeks prior to study initiation |
|
| ExclusionCriteria |
| Details |
1. Presence of vaginal or urinary tract infection
2.pelvic organ prolapse, severe vaginal atrophy with ulceration
3.use of systemic estrogen
4.use of vaginal lubricant |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.change in vaginal dryness severity from baseline to end of treatment measured using Vas score or vaginal dryness self assessment scale |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Associated symptoms improvement ( reduction in itching, burning) |
90 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
02/11/2025 |
| 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="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
|
A pilot study on the efficacy of oral satavar and vaginal pessary of Rogan e gul and camphor in the management of Vaginal dryness
Aim : To evaluate the effectiveness of oral satavar ( Asparagus racemosus ) in combination with vaginal pessary of camphor and Rogan e gul in the management of Vaginal dryness among Post menopausal woman.
Inclusion criteria: 1.woman aged 40-60 years. 2. Presence of at least one symptoms such as itching,burning,discomfort or pain during intercourse for at least past 3 months. 3.menopausal status Postmenopausal woman ( greater than 12 months since last menstrual period) 4. No use of systemic estrogen therapy, hormonal contraceptive or vaginal lubricant for at least 2 weeks prior to study initiation
Exclusion criteria: 1. Presence of vaginal or urinary tract infection 2.pelvic organ prolapse, severe atrophic vaginitis 3. Use of systemic estrogen 4. Use of vaginal lubricant
Primary outcome: Change in vaginal dryness severity from baseline to end of treatment measured using Vas score or vaginal dryness self assessment scale
Secondary outcome Associated symptoms improvement ( reduction in itching, burning)
Interventions: Test group 1. Oral satavar (Asparagus racemosus) Patient will be given 6gm of above mentioned drug powder per day for 90 days 2. Vaginal pessary of camphor and Rogan e gul Patient will be given vaginal pessary of above mentioned drug per day for 10 days for 3 consecutive months. |