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CTRI Number  CTRI/2025/03/082583 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Unani drug in comparison to conventional drug in the treatment of Dyslipidaemia (abnormal lipid level in blood) 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of Unani Formulation in the management of Khalal shahmiyyat al-dam (Dyslipidaemia) 
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 Iram Khan 
Designation  PG Scholar (National research institute of unani medicine for skin disorders) 
Affiliation   
Address  National Research Institute Of Unani Medicine For Skin Disorders,AG Colony Rd.,Opposite ESI Hospital,Eragadda,Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  8881512262  
Fax    
Email  khaniram2107@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arzeena Jabeen 
Designation  Professor 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department Of Moalajat,National Research Institute Of Unani Medicine For Skin Disorders,A.G.,Colony Rd.,Opposite ESI Hospital,Eragadda,Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  9032519286  
Fax    
Email  aarzu763@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arzeena Jabeen 
Designation  Professor 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department Of Moalajat,National Research Institute Of Unani Medicine For Skin Disorders,A.G.,Colony Rd.,Opposite ESI Hospital,Eragadda,Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  9032519286  
Fax    
Email  aarzu763@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute Of Unani Medicine For Skin Disorders,AG colony road opp.ESI hospital,Erragadda,Hyderabad,500038 
 
Primary Sponsor  
Name  National Research Institute Of Unani Medicine For Skin Disorders  
Address  A.G.Colony Road,Opposite ESI Hospital,Eragadda,Hyderabad-500038 
Type of Sponsor  Research institution and hospital 
 
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 Iram Khan  National Research Institute Of Unani Medicine   Dept.of Moalajat ,OPD block,room No. 1, A.G.Colony Rd.,Opposite ESI Hospital,Eragadda,Hyderabad-500038
Hyderabad
TELANGANA 
8881512262

khaniram2107@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,NRIUMSD,Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E789||Disorder of lipoprotein metabolism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A :Test group(Unani drug)  Unani formulation:Method of preparation-the test drug will be prepared in single batch as per the guidelines and method of preparation described in GHINA MINA .It will be properly cleaned and identified by the chief pharmacist before preparing a fine powder in GMP certified pharmacy of NRIUMSD. Dose and frequency:patient will be advised to take 4.5gm of safoof once a day at night after meal.Route of administration: oral Duration of therapy:12 weeks 
Comparator Agent  Group B:Active Control group(HMG-CoA Reductase inhibitors)  tablet Atorvastatin. Dose:20mg/day at night with water.Route of administration:oral. Duration of therapy:12 weeks  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  participants of any sex aged 20-60 years.participants having any one or more of the following lipid abnormality in blood:Total Cholesterol equal to or more than 200mg/dl.Serum LDL Cholesterol equal to or more than 130 mg/dl.Serum HDL Cholesterol less than 40mg/dl .Serum Triglyceride 150-400mg/dl.Body Mass Index 23-40 kg/m2 . 
 
ExclusionCriteria 
Details  Patients aged less than 20 years or more than 60 years.
Serum Triglyceride less than 150 mg/dl or more than 400 mg/dl.
Body Mass Index (BMI) less than 23 or more than 40 kg/m2.
Uncontrolled hypertension,diabetes mellitus,or other systemic diseases.
History of angina or myocardial infarction
Pregnant or Lactating Women.
Significant Pulmonary,Cardiovascular,Hepatic,or renal Dysfunction.
Immunocompromised states (HIV/ AIDS)/ Malignancies.
Unwillingness to adhere to the treatment schedule. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Biochemical assessment of the change in Lipid and Lipoprotein level.  At baseline and 8th week. 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in BMI , Waist Circumference,Hip and Waist Ratio and Weight.   At baseline and 8th week. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   02/06/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Dyslipidemia is a prevalent disorder characterized by abnormal levels of lipoproteins in the blood, leading to elevated serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides, while reducing high-density lipoprotein cholesterol (HDL-C) levels. It can be categorized into primary (genetic) and secondary (acquired) dyslipidemia, with the latter often resulting from lifestyle factors, co-morbid conditions, or medication use.

Recent epidemiological data suggest that over 50% of the adult population globally suffers from dyslipidemia, with a significant burden observed in both urban and rural populations in India . This condition significantly contributes to the development of atherosclerosis and cardiovascular diseases (CVD), which are leading causes of morbidity and mortality worldwide. According to the World Health Organization (WHO), cardiovascular diseases account for approximately 17.9 million deaths annually, emphasizing the urgent need for effective management strategies.

Untreated dyslipidaemia may leads to atherosclerotic cardiovascular diseases (ASCVD) mainly Ischemic Heart Diseases, cerebrovascular diseases, peripheral

arterial diseases, diabetes mellitus, hypertension, acute pancreatitis mainly due to triglycerides rich lipoprotein without increase in LDL-C.

Statins are the primary treatment for high LDL cholesterol, inhibiting its synthesis and enhancing LDL removal. Alternatives include bile acid sequestrants, cholesterol absorption inhibitors, fibrates, and niacin but all of these have some side effects including constipation, exacerbation of haemorrhoids, nausea, increased bleeding related to Vitamin-K malabsorption, Vitamin-A and Vitamin-D deficiencies.

The high prevalence of disease along with life-threatening complications at a cost of serious side effects associated with conventional medicine demands the search for a treatment that is safe, effective, economical, and easily accessible to alleviate such a complex disease with serious complications.In Unani System of Medicine, dyslipidemia is analogous to siman mufrit, attributed to an excess of dusumat (lipids) in the blood  and it is termed as Khalal Shahmiyyat al-Dam. Siman Mufrit is a disorder stemming from hazm-e-kabidi dysfunction and a predominance of cold temperament. Coldness causes  arteriosclerosis  (salabat), deposition  of  fat in  the  vessels leading  to  atherosclerosis  (tasaddud)  while  its  accumulation  in  body parts leads to obesity(Siman Mufrit).

In Unani System Of Medicine, there are various treatment modalities available for the management of Lifestyle disorder such as  dyslipidaemia: ilaj bil tadbeer (regimental therapy), ilaj bil ghiza (dietotherapy), and ilaj bil dawa (pharmacotherapy). In ‘ilaj bil dawa’, basic principle is ‘Ilaj bil- zid. The drugs which have hot and dry temperament and possessing Mulattif, Mujaffif, Mudir, Muhallil, Mufatteh, Muhazzil pharmacological properties are used in the treatment of siman mufrit.

After a thorough review of literature, a classical Unani formulation mentioned in unani literature GHINA MINA having indication for Siman-i-Mufrit has been selected for the present study. The selected Unani formulation includes ingredients such as Ajwain, Badyan, Zeera, Bora armani, Donamarwa/Marzanjosh, and Luk Maghsool, which have demonstrated lipid-lowering effects in previous pre-clinical studies. This clinical study is designed to systematically assess the efficacy and safety of this formulation in the management of dyslipidemia.

 

 
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