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CTRI Number  CTRI/2018/08/015468 [Registered on: 24/08/2018] 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 Habb-e-Tinkar 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeal formulation Habb-e-Tinkar in Zofe Ishtiha (Anorexia) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ZI/A/HT/CLNVAL/CCRUM 16-17  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 (Path) SIV 
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  
Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Srinagar 2. Regional Research Institute of Unani Medicine(RRIUM), Bhadrak 3. Regional Research Centre, Silchar 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  Central Council for Research in Unani Medicine(CCRUM), 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  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 Khursheed Khatoon  Central Research Institute of Unani Medicine  Research OPD Room (Zofe Ishtiha (Anorexia) AG Colony, Erragadda
Hyderabad
ANDHRA PRADESH 		 9296653033

dr.khursheedkhatoon@gmail.com 
Dr Syed Sadullah Hadi  Regional Research Centre  Research OPD Room (Zofe Ishtiha (Anorexia) NIUM, Kotigepalya, Magadi Road
Bangalore
KARNATAKA 		 9242753179

drhahdicru@gmail.com 
Dr Mohd Tariq  REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE  Research OPD Room (Zofe Ishtiha (Anorexia) Basaha, Kursi Road
Lucknow
UTTAR PRADESH 		 8299875352

drtariqnium@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Central Research Institute of Unani Medicine, Hyderabad  Approved 
Central Research Institute of Unani Medicine, Lucknow  Approved 
Clinical Research Unit Bangalore  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R630||Anorexia, Zofe Ishtiha (Anorexia),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Habb-e-Tinkar   Hab-e-Tinkar Pill (250 mg 2 tabs each) Twice daily Oral To be taken with water after meals for 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 Zofe Ishtiha (Anorexia)   2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Hematological and biochemical assessments for safety   2 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)   25/08/2018 
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 
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 Zofe Ishtiha (Anorexia)  After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically on Baseline, and after two weeks.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be fourteen days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy

Composition of Hab-e-Tinkar

S.No.

Ingredients

Quantity
  1.  

Sibr Zard

100g
  1.  

Filfil Siyah

75g
  1.  

Bazr ul banj

15g
  1.  

Tinkar Biryan

10g
  1.  

Loab e Gheekwar

10g

(NFUM-I, Page 35)

 
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