| CTRI Number |
CTRI/2024/07/071582 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of white discharge from vagina with Unani medicine Safoof Makhana |
|
Scientific Title of Study
|
Clinical validation of Unani Pharmacopoeial formulation Safoof Makhana in Sailan-ur-Reham (Leucorrhoea) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SR/L/SM/CLNVAL/CCRUM/2022-2023, version 01, 07.06.22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| 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 |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghazala Javed |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 506, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9811810454 |
| Fax |
|
| Email |
ghazala.javed@gov.in |
|
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 Central Research Institute of Unani Medicine, Lucknow; 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 Bushra Sabir |
Central Research Institute of Unani Medicine (CRIUM) |
Research OPD Room Sailan-ur-Reham (Leucorrhoea), Vill. & Post Basaha, Kursi Road
Lucknow
UTTAR PRADESH |
7503539832
dr.bushrasabir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Safoof Makhana |
6gm (Powder) orally with milk before breakfast for 28days |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients in the age group of 14-45 years.
2. Patients having excessive white discharge with or without any of the following associated symptoms
a. Waja‘ al-Zahr (Backache)
b. Naqahat (General Weakness)
c. Burning Micturition
d. Pruritus vulvae |
|
| ExclusionCriteria |
| Details |
1. Patients having acute/ acute on chronic/Chronic PIDs (as per the CDC Diagnostic Criteria attached as an annexure-V)
2. Patients with diseases requiring long-term treatment.
3. Patients on Oral Contraceptives/IUDs.
4. Patients taking hormonal therapy.
5. Any abnormal condition on p/s Examination.
6. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The efficacy of the study drugs will be assessed on the basis of improvement in the following symptoms for which a 10-point Visual Analog Scale (VAS) will be applied.
• Amount of Vaginal Discharge (rated according to the number of pads used in a day)
• Waja‘ al-Zahr (Backache)
• Naqahat (General Weakness)
• Burning Micturition
• Pruritus vulvae |
At baseline, 7th day, 14th day and at the end of study i.e. 28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination. |
At baseline and at the end of study i.e. 28days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
09/08/2024 |
| 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="2"
Months="0"
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
|
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 28days. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 28days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Safoof Makhana: | S.No | Ingredients | Quantity | | 1 | Salab Misri | 200g | | 2 | Tukhm-e-Talmakhana | 200g | | 3 | Satawar | 200g | | 4 | Ilaichi Khurd | 200g | |