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CTRI Number  CTRI/2024/11/076195 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 02/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Other 
Public Title of Study   Effect of Majun E Seer Alvi Khani on increased lipid levels across different Temperaments 
Scientific Title of Study   To Evaluate the Efficacy of Majun E Seer Alvi Khani On Fart E Tadassum Fid Dam Hyperlipidaemia Across Bilious and Phlegmatic Temperaments 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Afreen Begum 
Designation  PG Scholar 
Affiliation  Govt Nizamia Tibbi College and General Hospital 
Address  PG Department of Kulliyat e Tib(Principles Of Medicines) Government NizamiaTtibbi and General Hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  6303253520  
Fax    
Email  feroz.syed97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Yousufuddin 
Designation  HOD And Professor PG Department Of Kulliyat e Tib 
Affiliation  Govt Nizamia Tibbi College and General Hospital 
Address  OPD 6 Govt Nizamia Tibbi College And General Hospital Charminar Hyderabad Telangana

Hyderabad
TELANGANA
500002
India 
Phone  9912904786  
Fax    
Email  yousufmohd96@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Afreen Begum 
Designation  PG Scholar 
Affiliation  Govt Nizamia Tibbi College And General Hospital 
Address  PG Department of Kulliyat e Tib(Principles Of Medicines) Government NizamiaTtibbi and General Hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  6303253520  
Fax    
Email  feroz.syed97@gmail.com  
 
Source of Monetary or Material Support  
Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad Telangana 500002 India 
 
Primary Sponsor  
Name  PG Department of Kulliyat e Tib 
Address  OPD 6 Govt Nizamia Tibbi College and General Hospital Charminar Hyderabad Telangana 500002 India 
Type of Sponsor  Government medical college 
 
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 Afreen Begum  Govt. Nizamia Tibbi College and general Hospital  OPD No 6, Govt Nizamia Tibbi College and General Hospital, Charminar, hyderabad, Telangana
Hyderabad
TELANGANA 		 6303253520

feroz.syed97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E785||Hyperlipidemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Majun E Seer Alvi Khani  7 Grams Once a day after breakfast for the duration of 40 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of both gender
Patients who have not started hypolipidaemic agents yet
Mild to moderate ranges of different lipids in lipid profile
 
 
ExclusionCriteria 
Details  Pregnant and lactating females
Uncontrolled hypertension
Patients of chronic heart disease
Diabetic patients
Patients of chronic kidney disease
Inflammatory bowel syndrome and peptic ulcers
Tuberculosis
Patients having any malignancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in serum lipid levels in participants after 40 days of treatment with Majun E Seer Alvi Khani. Changes in lipid profiles will be measured from baseline to post-intervention to determine the efficacy of the formulation in managing hyperlipidaemia.

 		 1. BASELINE(day 0)
Collect demographic data, medical history and baseline temperamental assessment (bilious and phlegmatic)
Perform initial Lipid {Profile test

2. Day 40
End of treatment
Perform final lipid profile test to evaluate the efficacy of the treatment.
Assess Overall Wellbeing 
 
Secondary Outcome  
Outcome  TimePoints 
1. The effect of Majun E Seer Alvi Khani on participants’ overall well-being.
2. Any changes in body weight and BMI.
3. The incidence of any adverse effects during the course of the treatment. 		 1. BASELINE(day 0)
Collect demographic data, medical history and baseline temperamental assessment (bilious and phlegmatic)
Perform initial Lipid {Profile test

2. Day 40
End of treatment
Perform final lipid profile test to evaluate the efficacy of the treatment.
Assess Overall Wellbeing 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   20/11/2024 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This open-label clinical trial aims to assess the efficacy of Majun E Seer Alvi Khani in the management of hyperlipidaemia in patients with bilious and phlegmatic temperaments. A total of 60 participants with borderline lipid levels will be enrolled. Each participant will receive 7grams Majun E Seer Alvi Khani once daily after breakfast for 40 days. The primary objective is to evaluate the impact of this Unani formulation on lipid profiles and assess its efficacy in managing hyperlipidaemia in individuals of bilious and phlegmatic temperaments. 
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