| CTRI Number |
CTRI/2023/03/050475 [Registered on: 09/03/2023] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of whitish or yellowish vaginal discharge with Unani medicine Tiryaq e Reham |
|
Scientific Title of Study
|
Clinical validation of Unani pharmacopoeial formulation Tiryaq e Reham in Sailan ur Reham (Leucorrhoea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SR/L/TR/CLNVAL/CCRUM 20-21, version 01, 31/01/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine, Chennai Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
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 A Farhath Fathima |
Regional Research Institute of Unani Medicine, Chennai |
Reseach OPD Room Sailan ur Reham (Leucorrhoea), No. 1, West Mada Church Road, Royapuram
Chennai
TAMIL NADU |
9941767447
farhathcrony@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N899||Noninflammatory disorder of vagina, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tiryaq e Reham |
2 gms (semisolid) orally twice a day after meals with water for two weeks |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients in the age group of 13-45 years.
2. Patients having excessive vaginal discharge with or without any of the following associated symptoms
• Waja ‘al-Zahr (Backache)
• Naqahat (General Weakness) |
|
| ExclusionCriteria |
| Details |
1. Patients having acute / Chronic PIDs
2. Unexplained vaginal bleeding
3. Abnormal findings on pelvic sonography
4. Systemic disease like hypertension, diabetes, heart disease, tuberculosis,
5. Severe anaemia i.e. Hemoglobin < 8 gms%,
6. Patients on Oral Contraceptives / IUDs.
7. Patients taking hormonal therapy.
8. Any abnormality on pv Examination.
9. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Sailan ur Reham (Leucorrhoea) i.e. Amount of Vaginal Discharge (scoring according to the semi quantitative method), Waja ‘al-Zahr (backache), Naqahat (General Weakness) and improvement in abnormal findings of vaginal smear |
At baseline, 7th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
On baseline and 14th day |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
10/03/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a single centric open trial in patients with Sailan ur Reham (Leucorrhoea). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week for two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 2 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition
of Tiryaq e Reham
|
1
|
Gul e Supari
|
40
gms
|
|
2
|
Gul
e pista
|
40
gms
|
|
3
|
Simagh
dhak
|
40
gms
|
|
4
|
Inderjo
shireen
|
20
gms
|
|
5
|
Asgand
nagoori
|
20
gms
|
|
6
|
Kushta
qalai
|
3 gms
|
|
7
|
Kushta
marjan
|
3 gms
|
|
8
|
Kushta
aqeeq
|
1.5
gms
|
|
9
|
Misri
|
80 gms
|
|