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CTRI Number  CTRI/2015/02/005591 [Registered on: 27/02/2015] Trial Registered Retrospectively
Last Modified On: 03/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the Safety and efficacy of Unani formulations in the treatment of Anorexia 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial formulation Jawarish Ood Shireen in Zof al-Ishtihā (Anorexia)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ZI/AN/JOS/CLN VAL/CCRUM 13-14 Version no 1  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PROF S SHAKIR JAMIL  
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

West
DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  unanimedicine@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  dr k m siddiqui 
Designation  ASSISTANT DIRECTOR SCIENTIST 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

West
DELHI
110058
India 
Phone  9810161758  
Fax  01128522965  
Email  ccrum507@gmail.com  
 
Details of Contact Person
Public Query  
Name  dr pradeep kumar 
Designation  RESEARCH OFFICER SCIENTIST III 
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

West
DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  drpradeepkumar2001@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support : 1. Regional Research Institute of Unani Medicine, Bhadrak 2. Clinical Research Unit, Meerut 3. Clinical Research Unit, Kurnool 4. Clinical Research Unit, Kerala Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi  
 
Primary Sponsor  
Name  Central Council for Research in Unani MedicineCCRUM 
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  na 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR MOHD TARIQ KHAN  Clinical Research Unit   Gulzar-e- Ibrahim, Gali No. 2, Tanki Wali Gali, Bhomiya Ka Pul, lesari Road
Meerut
UTTAR PRADESH 		 09012843253

doctormtk@gmail.com 
Dr Jawadul Haq   Clinical Research Unit, Kurnool  DR ABDUL HAQ UNANI MEDICAL COLLEGE, 40/23 PARK ROAD
Kurnool
ANDHRA PRADESH 		 09502443555

cru.kurnool@gmail.com 
DR SYED ABDULLAH HUSSANI  Regional Research Institute of Unani Medicine, Bhadrak  Motel Chhak, Mathasahi
Bhadrak
ORISSA 		 09040318584

abuasad_65@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Clinical Research Unit  Approved 
Clinical Research Unit, Kurnool  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 al-Ishtihā (Anorexia),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Jawarish Ood Shireen  Jawarish Ood Shireen, 5 gm Orally, BD with water before meals for a period of two weeks  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  •Patients of either sex in the age group of 18-65
•Decreased Appetite with SNAQ ≤ 14
 
 
ExclusionCriteria 
Details  •Patients having Anorexia nervosa
•Patients with disorders requiring long term treatment
•Known cases of Hepatic, Renal or Cardiac Ailments
•History of addictions (Alcohol, Drugs)
•Pregnant and lactating women
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms   2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Hematological and biochemical assessments for safety  2 weeks 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/02/2014 
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)  Open to Recruitment 
Publication Details   nil 
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 Khafaqan (Palpitation)  After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically every week.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 04 weeks. . Laboratory parameters for safety assessment will be conducted at baseline, first follow up and on completion of the protocol therapy. 
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