| CTRI Number |
CTRI/2025/07/091259 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| 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 Kushta-i-Sadaf
|
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Kushta-i-Sadaf in Sayalan al-Rahim due to Sue Mizaj Sada (Non-specific leucorrhoea) |
| Trial Acronym |
leucorrhoea |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SR/L/KS/CLNVAL/CCRUM/23-24, Version No-01 |
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
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 India
South West
DELHI
110058
India |
| Phone |
09811810454 |
| Fax |
|
| Email |
javed.ghazal@gmail.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 India
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support :Regional Research Institute of Unani Medicine,
Kazmi Begum Colony, Gujari Bazar, Sadikpur,Patna City,
Patna– 800008 |
|
|
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 Zikra Tahseen A |
Regional Research Institute of Unani Medicine |
Research OPD Room,sailan-ur-reham(Leucorrhea),Guzri, Patna City,
Patna
Patna
BIHAR |
7904031411
zikra0210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N89||Other noninflammatory disorders ofvagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kushta-i-Sadaf |
200 mg twice in a day with water
after meals for 04 weeks (28 days). |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
All women complaining of excessive white discharge with or without any of the following associated symptoms:
1. Waja‘ al-Zahr (Backache)
2. Naqahat (General Weakness)
3. Burning Micturition
4. Pruritus vulvae |
|
| ExclusionCriteria |
| Details |
1. Age below 15 & above 49 years
2. Patient with severe anemia (Hb % Equal or less than 8gm)
3. Known cases of uterine fibroid, prolapse, malignancy and ovarian tumour or cyst
4. Patients on oral contraceptive pills (OCPs)/Intrauterine devices (IUDs)/ Hormonal Replacement Therapy (HRT)
5. Known cases of sexually transmitted diseases
6. Patients on long-term medications for systemic illnesses
7. Any abnormal condition on p/s Examination
8. Patients having acute / acute on chronic/ Chronic PID as per CDC Criteria.
9. Pregnant and Lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of the Habb -e- Leemun in the treatment of Niqris (Chronic Gout) will be carried out on the basis of Pain (VAS-Visual Analogue Scale) and Gout Assessment Questionnaire. |
At baseline and at the end of treatment. i.e, 0 & 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical investigations for safety assessment i.e., Hemogram,LFT, KFT, Urine Examination: Routine & Microscopic. |
At baseline and at the end of treatment. i.e, 0 & 4th week
|
|
|
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 2 |
|
Date of First Enrollment (India)
|
29/07/2025 |
| 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="2"
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
|
This study is designed as a Single-centric open trial in patients with Sayalan al- Rahim (Non-specific leucorrhoea). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. Efficacy and safety parameters will be assessed clinically and recorded every week. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 4 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Detail of pharmacopeial formulation (NUFM-Part I, P. No 75) | S. No. | Ingredients | Quantity | | 1. | Sadaf Kalan | 250 gm | | 2. | Sheer Madar | Q.S. |
|