| CTRI Number |
CTRI/2023/07/055320 [Registered on: 18/07/2023] Trial Registered Prospectively |
| Last Modified On: |
17/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of abnormal cholesterol levels in the blood with Unani medicine |
|
Scientific Title of Study
|
Evaluation of the safety and efficacy of Qurs Tinkar for the management of dyslipidemia - A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Salma Khatoon |
| Designation |
PG Scholar |
| Affiliation |
Luqman Unani Medical College Hospital and Research Center |
| Address |
Department of Moalajat, Luqman Unani Medical College Hospital and Research Centre Naubag Vijaypur 586101
Bijapur
KARNATAKA
586101
India |
| Phone |
8904316524 |
| Fax |
|
| Email |
salmakhatoonmomin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Qudrathullah Khan |
| Designation |
Professor and HOD |
| Affiliation |
Luqman Unani Medical College Hospital and Research Center |
| Address |
Department of Moalajat, Luqman Unani Medical College Hospital and Research Centre Naubag Vijaypur 586101
Bijapur
KARNATAKA
586101
India |
| Phone |
9849438319 |
| Fax |
|
| Email |
drmqkhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
D Nazim Husain |
| Designation |
Assistant Professor |
| Affiliation |
Luqman Unani Medical College Hospital and Research Center |
| Address |
Department of Moalajat, Luqman Unani Medical College Hospital and Research Centre Naubag Vijaypur 586101
Bijapur
KARNATAKA
586101
India |
| Phone |
9212143572 |
| Fax |
|
| Email |
dr.nazimhusain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Luqman Unani Medical College and Research Centre, Vijaypur, Karnataka, 586101 |
|
|
Primary Sponsor
|
| Name |
Luqman Unani Medical college hospital and research centre |
| Address |
Luqman unani medical college hospital and reseach centre naubaag bijapur |
| Type of Sponsor |
Private medical college |
|
|
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 Salma Khatoon |
Luqman Unani Medical College Hospital and Research Centre |
Ground Floor, PG-OPD No. 1, Department of Maolajat, Luqman Unani Medical College Hospital and Reach centre, Vijaypur, Karnataka, India, 586101
Bijapur
KARNATAKA |
9620158823
salmakhatoonmomin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Luqman Unani Medical College Hospital and Research Centre, Vjaypur, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atorvastatin |
20mg once a day after meals at night for 3 months |
| Intervention |
Qurs Tinkar |
2 tablets of 500mg each twice daily with water after meals for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Participants of any gender.
-Age between 20 and 60 years.
-Participants with serum cholesterol more than or equal to 200mg per dL, serum triglycerides(TG) more than or equal to 150mg per dL, Low Density Lipoprotein cholesterol (LDL) more than or equal to 130mg per dL, High Density Lipoprotein (HDL) less than or equal to 40 mg per dL.
|
|
| ExclusionCriteria |
| Details |
-Participants with comorbidities such as IHD, hypertension, diabetes, chronic kidney disease, malignancy, and other aggravating conditions.
-Pregnant & lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in the levels of:
LDL-C
HDL-C |
At baseline and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the levels of:
Total cholesterol,
Triglycerides,
Non-HDL-C,
Very Low Density Lipoprotein VLDL,
Total Cholesterol HDL Cholesterol Ratio,
FBS,
SGOT,
SGPT,
ALP,
Serum Creatinine, &
Blood Urea Nitrogen |
At baseline & 3 months. |
|
|
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)
|
28/07/2023 |
| 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="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [salmakhatoonmomin@gmail.com].
- For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dyslipidemia is a group of lipoprotein metabolism diseases characterized by increased serum total cholesterol, triglycerides and LDL, and decreased serum cholesterol concentration and HDL This is the most significant risk factor for cardiovascular diseases and atherosclerosis. In India, the prevalence of hypercholesterolemia ranges from 10-15 in rural areas to 25-30 in metropolitan areas. However, this prevalence is lower than in countries with a high income. Several health behaviors, including cigarette use, physical inactivity, diet, and obesity, can have affects and elevate lipid levels However, there is a complex relationship between obesity and dyslipidemia, which influences insulin resistance and body fat metabolism directly. In addition, because dyslipidemia affects lipid metabolism, it is commonly accompanied by obesity. Excessive fat deposition in obesity also has a complex origin but is commonly attributed to an imbalance between energy expenditure and energy intake. Despite special public health measures and individual treatment initiatives to tackle the obesity epidemic, more than 2 billion individuals are overweight or obese worldwide. Initial management for dyslipidemia involves lifestyle modifications and then lipid lowering thrapies.
First-line treatment for dyslipidemia is statins that inhibit HMG-CoA reductase The limitations of present therapy, the high incidence of the disease, life-threatening consequences, and the side effects of conventional medicines have increased the potential for the creation of a safe, effective, and economical therapeutic intervention for dyslipidaemia.
Unani medicine, which is based on Hippocratic concepts, may offer preventative strategies, therapeutic techniques, and medications to treat dyslipidemia. Although there is no direct description of dyslipidemia in Unani literature, scholars have characterized it under the general titles of Dasumat-i Dam (greasy blood) and Siman-i Mufrit (excessive fat condition), as well as the abnormalities of Hazm-i Kabidi (hepatic digestion), as the primary cause of dyslipidemia The principles of treatment revolve around TajfÄ«f-i Badan (desiccation), TahzÄ«l (weight loss), and TaqlÄ«l-i GhizÄ (reduction in the quantity of food) . Pharmacologically a number single and compound drugs are prescribed by renowned Unani scholars in ancient literature in which Qurs Tinkar is prescribed to reduce fat and constipation , but scientific evidence is scarce.
Thus, present study is designed to compare the safety and efficacy of Qurs Tinkar with atorvastatin in the management of dyslipidemia. |