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CTRI Number  CTRI/2013/10/004116 [Registered on: 30/10/2013] 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 Hyperacidity 
Scientific Title of Study   Validation of Unani Pharmacopoeial formulation in Kasrat- e- Ratubat-e-Hamoozi (Hyperacidity)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abdul Hannan  
Designation  JOINT DIRECTOR 
Affiliation  Central Council for Research in Unani Medicine (CCRUM),  
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-
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-
New Delhi
DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  ccrum605@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abdul Hannan  
Designation  JOINT DIRECTOR 
Affiliation  Central Council for Research in Unani Medicine (CCRUM),  
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-
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-

DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  ccrum605@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abdul Hannan  
Designation  JOINT DIRECTOR 
Affiliation  Central Council for Research in Unani Medicine (CCRUM),  
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-
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-

DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  ccrum605@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine (CCRUM),  
 
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  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 S MANZAR AHSAN  Regional Research Institute of Unani Medicine (RRIUM), Patna  Second Floor, Shri Guru Gobind Singh Hospital, Patna – 800 008 Patna BIHAR
Patna
BIHAR 		 06122631106

manzarahsan9@gmail.com 
DR RIFAT M AFRIDI  Regional Research Institute of Unani Medicine, Aligarh  Post Box 70, Near Head Post Office, ALIGARH – 202 001
Aligarh
UTTAR PRADESH 		 0571-2704781

afridirifat@gmail.com 
Dr Arjumand Shah  Regional Research Institute of Unani Medicine, Srinagar  University of Kashmir, Srinagar-190006
Srinagar
JAMMU & KASHMIR 		 0194-2421604

arjusaju@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
RRIUM ALIGARH INSTITUTIONAL ETHICS COMMITTEE, ALIGARH, DR RIFIT M AFRIDI, PRINCIPAL INVESTIGATOR  Approved 
RRIUM PATNA INSTITUTIONAL ETHICS COMMITTEE, PATNA, DR S MANZAR AHSAN, PRINCIPAL INVESTIGATOR  Approved 
RRIUM SRINAGAR INSTITUTIONAL ETHICS COMMITTEE, SRINAGAR, JAMMU & KASHMIR, DR Dr Arjumand Shah, PRINCIPAL INVESTIGATOR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K290||Acute gastritis, hyperacidity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Jawarish Amla 2. Habb e Papita   1. Jawarish Amla will be given in 10 gm twice daily at morning and evening with water. 2. Habb e Papita will be given twice after meals with water  
Comparator Agent  NOT APPLICABLE  NIL APPLICABLE 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Subjects in the Age group of 18-60 years
• Subjects of both sexes
• Subjects presenting with the following symptoms :
o Retrosternal burning
o Epigastric pain with retrosternal heaviness
o Acidic brash
o Anorexia
o Nausea
o Vomiting
o Pain relieved after vomiting
 
 
ExclusionCriteria 
Details  • Duodenal ulcer
• Peptic ulcer
• H/o previous gastric surgery
• Presence of cardiac & lung diseases
• Pregnancy/lactation
• Alcoholism
• Diabetes
• Stomach carcinoma
• Crohn’s Diseases
• Allergy/Intolerance to any ingredients of the drug1,9,12.
• Zollinger Ellison Syndrome
 
 
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   6 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
Outcome TimePoints
Hematological and biochemical assessments for safety
 		 6 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)   02/11/2011 
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 Kasrat- e- Ratubat-e-Hamoozi  (hyperacidity). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on each fortnightly follow up. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 06 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study. 
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