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CTRI Number  CTRI/2019/03/017950 [Registered on: 06/03/2019] Trial Registered Prospectively
Last Modified On: 12/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Excessive abnormal white vaginal Discharge with Unani medicine Majoon Sohag Sonth 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial Formulation Majoon Sohag Sonth in Sayalān al-Rahim (Excessive Abnormal Vaginal Discharge) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SR/EAVD/MSS/CLNVAL/CCRUM/17-18, version 1  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  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  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  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 (CRIUM), Lucknow 2. Regional Research Institute of Unani Medicine (RRIUM), Srinagar 3. Clinical Research Unit (CRU), Meerut Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine CCRUM 
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  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Najmus Sehar  Central Research Institute of Unani Medicine (CRIUM)  Basaha, Kursi Road Research OPD Room (Niswan)
Lucknow
UTTAR PRADESH 		 7903422298

nsehar.ccrum@gmail.com 
Dr Syed Ahmad khan  Clinical Research Unit (CRU)  Cantonment General Hospital, Begum Bridge (Soti Ganj) Research OPD Room (Niswan)
Meerut
UTTAR PRADESH 		 9810429359

crumeerut@gmail.com 
Dr Arjumand Shah  Regional Research Institute of Unani Medicine (RRIUM)  Gynae Research OPD Room, Naseem Bagh Campus, University of Kashmir Research OPD Room (Niswan)
Srinagar
JAMMU & KASHMIR 		 01942421604

arjusaju@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Central Research Institute of Unani Medicine, Lucknow  Approved 
Clinical Research Unit, Meerut  Submittted/Under Review 
Regional Research Institute of Unani Medicine, Srinagar  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N89||Other noninflammatory disorders ofvagina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Majoon Sohag Sonth   7 gms orally twice daily after meals with water for four weeks 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Sexually active women of age group 18 – 45 years.
2. All women complaining of vaginal discharge.
3. Associated symptoms:
a. Vulval Itching
b. Low Backache
c. Generalised weakness
d. Burning Micturition
e. Abnormal Vaginal Odour 
 
ExclusionCriteria 
Details  1. Menopausal, Pregnant and Lactating women.
2. Patient having any systemic illness like hypertension, diabetes mellitus.
3. Patients with fibroid, polyp, ovarian tumour or cyst, prolapse and malignancy.
Patients using OCPs or intrauterine devices.
4. Sexually transmitted diseases like HIV, VDRL.
5. Patients on long-term medications.
6. Abnormal findings on pelvic sonography.
7. Patients having acute / acute on chronic/ Chronic PID as per CDC Criteria
(Annexure-V) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of Sayalān al-Rahim (Excessive Abnormal Vaginal Discharge)  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessment for safety assessment  Investigations will be done at baseline and end of treatment 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   08/03/2019 
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   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is designed as a multicentric open trial in patients with Sayalān al-Rahim (Excessive Abnormal Vaginal Discharge) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically on Baseline and of treatment.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be four weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of Sharbat Sadar

S.No.

Ingredients

Scientific Name

Quantity
  1.  

Zanjabeel

Zingiber Officinalis

200 gm
  1.  

Rougan Zard

Ghee

200 gm
  1.  

Sheer e Gao

Cow’s Milk

1.2 litre
  1.  

Qand Safaid

Sugar

1 kg
  1.  

Maghz-e-Tukhm-e-Kharbuza

Cucumis melo Linn.

50 gm
  1.  

Maghz-e-Habb-us-samena

Buchanauia angustifolia Roxb.

40 gm
  1.  

Nishasta Gandum

Triticum aestivum Linn.

40 gm
  1.  

Asgand

Withania Somnifera Dunal.

20 gm
  1.  

Musli Safaid

Chlorphytum arundinaceum baker.

20 gm
  1.  

Mocharas

Salmalia malabarica

20 gm
  1.  

Samagh e Arabi

Acacia arabica

20 gm
  1.  

Satawar

Asparagus racemosus Willd.

20 gm
  1.  

Sazaj Hindi

Cinnamomum tamala

15 gm
  1.  

Sandal Safaid

Santalum album Linn.

15 gm
  1.  

Saleekha

Cinnamomum cassia Blume.

15 gm
  1.  

Gul-e-Dhawa

Anogeissus Latifolia

15 gm
  1.  

Khar-e-Khasak

Tribulus terrestris Linn.

10 gm
  1.  

Filfil Daraz

Piper longum Linn.

10 gm
  1.  

Filfil Siyah

Piper nigrum Linn.

10 gm
  1.  

Sunbul-ut-Teeb

Nardostachys jatamansi Dc.

10 gm
  1.  

Saad Kufi

Cyperus rotundus Linn.

10 gm
  1.  

Maghz-e-Tukhm-e-Konch

Mucuna Prurita Hook

10 gm

23.

Samagh-e-Dhak

Butea monosperma

10 gm

 
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