| 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
|
|
|
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
|
|
|
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. |