| CTRI Number |
CTRI/2020/09/028106 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
27/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Herbal Unani Medicine on unhealthy levels of one or more kind of lipid (fat) in blood. |
|
Scientific Title of Study
|
Efficacy of Unani formulation in Dyslipidemia-
An open labelled interventional clinical trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Faisal habib |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF UNANI MEDICINE |
| Address |
NATIONAL INSTITUTE OF UNANI
MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91
Bangalore KARNATAKA 560091 India |
| Phone |
9267438329 |
| Fax |
|
| Email |
faisalhabib0571@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Mansoor Ahmed Siddiqui |
| Designation |
Professor |
| Affiliation |
NATIONAL INSTITUE OF UNANI MEDICINE |
| Address |
NATIONAL INSTITUTE OF UNANI
MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91
Bangalore KARNATAKA 560091 India |
| Phone |
9448124054 |
| Fax |
|
| Email |
mansoorsiddiquidr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Mansoor Ahmed Siddiqui |
| Designation |
Professor |
| Affiliation |
NATIONAL INSTITUE OF UNANI MEDICINE |
| Address |
NATIONAL INSTITUTE OF UNANI
MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91
Bangalore KARNATAKA 560091 India |
| Phone |
9448124054 |
| Fax |
|
| Email |
mansoorsiddiquidr@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF UNANI
MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91
|
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUE OF UNANI MEDICINE |
| Address |
NATIONAL INSTITUTE OF UNANI
MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91
|
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Faisal habib |
NATIONAL INSTITUTE OF UNANI MEDICINE |
OPD/IPD of Dept. of Moalajat
NATIONAL INSTITUTE OF UNANI
MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD BANGALORE-91 Bangalore KARNATAKA |
9267438329
faisalhabib0571@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E788||Other disorders of lipoprotein metabolism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Unani formulation |
Test drug will be given orally in a dose of 4.5 grams powder with lukewarm water in morning in an empty stomach.
By giving the instruction to patients- NOT to take any meal up to 30 mins after oral administration of powder.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
BMI between 25-35 kg/m2
A) LDL-cholesterol:130-159mg/dl(Borderline high)8
B)Totalcholesterol:200-239mg/dl(Borderline High)8
C)HDL-cholesterol:<40mg/dl(low) &>60mg/dl(High)8
D)Serum Triglycerides:200-499mg/dl(High)8
Patient who will give consent and able to do follow up.
|
|
| ExclusionCriteria |
| Details |
1. Patient below the age of 20 years and above the age of 55 years
2. Pregnant and lactating mothers
3. Patient with systemic illness such malignancy, liver, kidney dysfunction, T.B. etc.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effects on TGL, HDL, LDL, VLDL, TC (normal/decrease). |
0th day and 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BMI, Waist Circumference, Hip and Waist Ratio, Weight in Kgs |
0th day, 14th day, 28th day, 42nd days. |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
05/10/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The dyslipidaemia is a state of abnormal levels of lipids (e.g. triglycerides, cholesterol and/or fat Phospholipids) in the plasma1. It is characterised as hypercholesterolemia, low level of high density of lipoproteins (HDL) and triglyceridemia. Dyslipidemia is the major risk factor for the cardiovascular disease and is estimated to cause 2.6 million death and 29.7 million disability adjusted life year’s globally. According to the World Health Organisation, the prevalence of dyslipidemia in the south east Asia (30%), and the western pacific (36.7%) were much lower than that in Europe (53.7%) and the Americas (47.7%). However, the prevalence of it across the Asia pacific region varies.If dyslipidemia not monitored and left untreated, affects the overall health status of an individual which may lead to overall hardening of the arteries in the later years of life. Similarly atherosclerosis is a condition described in conventional medicine occurs due to excess deposition of lipids in vessels and finally it can lead to MI and sudden death . Multiple epidemiologic studies have demonstrated a strong relationship between plasma levels of LDL-C and CHD. A direct connection between plasma cholesterol levels and the atherosclerotic process was made in humans.In modern system of medicine, the dyslipidemia is treated by following ways: Life style modification, exercise, diet, revascularisation and medication. Statins are the cornerstone of lipid lowering treatment. Several different types of statins with different pharmacological structures are now available as well as other lipids lowering drugs, plasma lipids levels, particularly those of LDL often are not optimally lowered to reach the recommended levels Keeping this view, the adverse effects of statins, various experts of different fields are exploring the methods to control the effects of lipids abnormalities. In Unani System of Medicine various formulation has been indicated for the condition like dyslipidemia. The management is described under the caption of dasoomat-e-dam, therefore principle of treatment of dyslipidemia given on the same line of treatment of dasoomat-e-dam. The Unani formulation constitute following drugs which will be given in the form of powder: Badyan, Zeerakirmani, Bora armani, Suddab, Marzanjoshkhushk, Lukmaghsool, Nankhwah. |