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CTRI Number  CTRI/2021/04/032937 [Registered on: 19/04/2021] Trial Registered Prospectively
Last Modified On: 16/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   It is a clinical trial on obesity 
Scientific Title of Study   A clinical comparative study on therapeutic formulation of (Ajwain, Tukhme Suddab, Zeera) versus of Tareeq(Diaphoresis) in the management of Simane Mufrit(Obesity) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammed Sheeraz 
Designation  Research Officer Unani 
Affiliation  Regional Research Institute of Unani Medicine Srinagar 
Address  Regional Research Institute of Unani Medicine Srinagar
Mughal lane 7 Srinagar
Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9797750472  
Fax    
Email  sheerazrrium@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mohammed Sheeraz 
Designation  Research Officer Unani 
Affiliation  Regional Research Institute of Unani Medicine Srinagar 
Address  Regional Research Institute of Unani Medicine Srinagar
Mughal lane 7 Srinagar
Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9797750472  
Fax    
Email  sheerazrrium@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mohammed Sheeraz 
Designation  Research Officer Unani 
Affiliation  Regional Research Institute of Unani Medicine Srinagar 
Address  Regional Research Institute of Unani Medicine Srinagar
Mughal lane 7 Srinagar
Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9797750472  
Fax    
Email  sheerazrrium@gmail.com  
 
Source of Monetary or Material Support  
Central Council for research in unani medicine, New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine New Dehli 
Address  Regional Research Institute of Unani medicine( RRIUM), University of kashmir , Srinagar CCRUM new dehli 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nazmeen  Regional Research Institute of Unani Medicine (RRIUM)  Moalajat OPD-1 Ground Floor, Department of Moalajat RRIUM,Naseem bagh Campus University of kashmir, Srinagar, JAMMU & KASHMIR
Srinagar
JAMMU & KASHMIR 		 6006243423

nazmeenamu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,RRIUM,Srinagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Safoof (powder) of unani formulation  Ingredients: Ajwain,tukhme sudaab,zeera Method of prepration Powder of all the drugs will be prepared as per standard procedure. Dose : 5gms Frequency : twice a day Route of administration : Oral Duration of therapy : 60 days  
Comparator Agent  Steam bath (Hammam-e-Bukhari)  Full body steam will be given as per standard procedure in full body steam chamber for 15 minutes without clothes unless and until patient will start sweating. Duration of therapy : 15 minutes Duration of therapy : 60 days Patient will be given steam bath twice weekly in 1st month And weekly steam bath in 2nd month 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  BMI>30
Waist circumference >102cm in men and 88 cms in women.
Patient who are ready to sign the consent. 
 
ExclusionCriteria 
Details  BMI<30.
Patients below 20 and above 60 years.
Patients who fail to give the written consent.
Pregnant and lacatating women.
Patients having local wounds and infections.
Unstable, bed ridden and mentally retarded patients
Patients of portal hypertension , cardiovascular disease, bleeding disorders, diabetes mellitus and contraceptive treatment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Bmi should reduce. Reduction in skin fold thickness  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Lipid profile cbc ecg  60 days 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   30/04/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/04/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Obesity is a condition of excess adipose tissue mass.Obesity is divided into three types; Simple obesity or primary obesity, secondary obesity and drug induced obesity. The prevalence of obesity is higher in women than men. The prevalence of obesity is low in people with low socio-economic status and in those who do more physical work. Body Mass Index is best measure for obesity which is equal to weightheight in the meter square (in kg /m²). According to WHO a person is called obese if BMI is >30 and a person is called overweight if BMI is ≥25.4 Some predisposing factors which are responsible for obesity are unhealthy diet, lack of physical activity, and sedentary life style. Apart from these some other causes responsible for obesity are  high energy food, saturated fat, trans- fats, more diet containing high quantity of sugar. In Unani system of medicine obesity is also known as Siman-e-Mufrit. The causes of obesity mentioned in the Unani literature are luxurious life style, lack of exercise,  Muraghghan ghizaen (fatty diet), all Martoob (moist things) which produces Ratubat in the body like Farhat (excess happiness). Many complication of obesity are Gastrointestinal disorders, Pseudo-tumour cereberi, Asthma, Gallstones, Backach.Keeping in view the side effects of modern medicine, nowadays people need the alternative management of obesity. In Unani system of medicine our therapeutic formulation (Ajwain, Tukhm-e-Suddab, Zeera) is effective treatment for the management of obesity as recommended by old Unani physicians. Hammām is one of the effective regimen for the management of obesity as described in Unani classical texts. Patient is placed into the bath chamber for a duration till the diaphoresis occur ,So in this regard the present study entitled “A clinical comparative study on therapeutic formulation of (Ajwain, Tukhm-e-Suddab, Zeera) versus Tareeq (diaphoresis) in the management of Siman-e-Mufrit (obesity)”is designed for validation and evaluation of safety and efficacy. 
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