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CTRI Number  CTRI/2018/08/015449 [Registered on: 23/08/2018] Trial Registered Prospectively
Last Modified On: 04/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Anorexia with Unani Medicine Jawarish-e-Zanjabeel. 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeal formulation Jawarish-e-Zanjabeel in Zof-e-Ishteha (Anorexia) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ZI/A/JZ/CLNVAL/CCRUM 16-17 version 1  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Naheed Parveen 
Designation  Assistant Director (Unani)  
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    
Fax    
Email  ccrum507@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naheed Parveen 
Designation  Assistant Director (Unani)  
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    
Fax    
Email  ccrum507@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Kumar 
Designation  Research Officer Scientist IV (Path) 
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    
Fax    
Email  drpradeepkumar2001@yahoo.com  
 
Source of Monetary or Material Support  
Source of Monetary or Material Support Infrastructural support : 1 Regional Research Institute of Unani Medicine (CRIUM), Aligarh 2. Regional Research Institute of Unani Medicine(RRIUM), Bhadrak 3 Clinical Research Unit (CRU) Burhanpur 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 South West DELHI 110058 India  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 S Noor Mohammad  Clinical Research Unit (CRU) Burhanpur  Research OPD Room (Zof-e-Ishteha (Anorexia) S H Unani Tibbia College, Ganpati Naka
West Nimar
MADHYA PRADESH 		 08109462242

mahajankk@rediffmail.com 
Dr Rashidullah Islam  Regional Research Institute of Unani Medicine  Research OPD Room (Zof-e-Ishteha (Anorexia) Post Box 70 Near Head Post Office
Aligarh
UTTAR PRADESH 		 9897975161

waytorashid@gmail.com 
Dr Syed Abdullah Hussaini  Regional Research Institute of Unani Medicine  Research OPD Room (Zof-e-Ishteha (Anorexia) Chandbali By Pass Road Near Rural Police Station
Bhadrak
ORISSA 		 7780275722

rriumbdk_unani@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Clinical Research Unit (CRU) Burhanpur  Submittted/Under Review 
Regional Research Institute of Unani Medicine  Approved 
Regional Research Institute of Unani Medicine Bhadrak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R630||Anorexia, Zof-e-Ishteha (Anorexia),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Jawarish-e-Zanjabeel   Jawarish –e-Zanjabeel Semi solid 7g Twice daily oral to be taken with water after meals two weeks  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of any sex in the age group 19-65 years
2. Patients having Zu‘f al-Ishtihā’ (Anorexia) with SNAQ score ≤ 14
 
 
ExclusionCriteria 
Details  1. Patients having Anorexia nervosa
2. Patients having any systemic disease, chronic debilitating disease, T.B., Diabetes Mellitus etc.
3. Known cases of Hepatic, Renal or Cardiac Ailments
4. History of hypersensitivity to study drug or any of its ingredients.
5. History of addiction (Alcohol, Drugs)
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 
Improvement in the sign and symptoms of Nisyān (Amnesia)  Two Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Hematological and biochemical assessments for safety   two weeks 
 
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 2 
Date of First Enrollment (India)   24/08/2018 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a multicentric open trial in patients with Zof-e-Ishteha (Anorexia)  After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every weekly.  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 Jawarish –e-Zanjabeel (NFUM-I, Page 106)

S. No.

Ingredients

Quantity
  1.  

Zanjabeel

100g
  1.  

Samagh e Arabi

50 g
  1.  

Dana Heel Khurd

50 g
  1.  

Belgiri

50g
  1.  

Saleekha

25g
  1.  

Zarambad

10g
  1.  

Nishasta e Gandum

200g
  1.  

Qand e safaid

450g
 
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