| CTRI Number |
CTRI/2018/06/014407 [Registered on: 05/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Behavioral
Other (Specify) [Hammam and Massage] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Prevention of Non Communicable diseases in Unani System of Medicine |
|
Scientific Title of Study
|
Reducing risk factors of metabolic syndrome using a Unani personalized programme |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nida talat |
| Designation |
PG scholar |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Dept. of tahaffuzi wa samaji tibb , National institute of Unani medicine, Kottigepalya, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
7204985692 |
| Fax |
|
| Email |
nidatalat1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zarnigar |
| Designation |
Lecturer |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept. of tahaffuzi wa samaji tibb , National institute of Unani medicine, Kottigepalya, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
7022669959 |
| Fax |
|
| Email |
Zarnigarriaz@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nida talat |
| Designation |
PG scholar |
| Affiliation |
RGUHS |
| Address |
Dept. of tahaffuzi wa samaji tibb , National institute of Unani medicine, Kottigepalya, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
7204985692 |
| Fax |
|
| Email |
nidatalat1987@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine Kottigepalya Bangalore 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani medicine |
| Address |
National Institute of Unani medicine, Kottigepalya, Bangalore, karnataka, 560091 |
| 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 |
| Nida Talat |
National Institute of Unani Medicine |
Department Of Tahaffuzi Wa Samaji Tibb OPD -3
Bangalore
KARNATAKA |
7204985692
nidatalat1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Metabolic Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Allopathic oral drugs |
1 Metformin 500mg twice daily orally for two months
2 Amlodipine 5mg orally once daily for two months
3 Atorvastatin 10mg orally once daily for two months |
| Intervention |
Unani personalized programme |
1 Dalk Khashn (whole body) with Roghan e Shibbat for 30 minutes twice weekly for two months.
2 Brisk walking for 45 minutes daily for two months
3 Dalk Isterdad 10 minutes twice weekly for two months
4 Hammam 20 minutes twice weekly for two months
5 Medicated drink prepared from Filfil (Piper nigrum) 2 parts, Karafs (Apiumgraveolans) 2 parts, Asaroon (ValerianaWallichii) half part, Anisoon (Pimpinellaanisum) half part. orally joshanda of 5gm formulation two times daily with sirka unsul 12ml (1 tola)for two months.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with three or more of the following features-3
1 Central obesity waist circumference > 90 cm in Male, >80 cm in Female
2 Hypertriglyceridemia; triglycerides ≥ 150 mg/dl
3 Low HDL cholesterol<40 mg/dl in males and <50 mg/dl in females
4 BP ≥130/ 85 mmHg
5 Fasting plasma glucose ≥ 100mg/dl
|
|
| ExclusionCriteria |
| Details |
1 All types of heart, liver and kidney diseases
2 Pregnancy
3 Lactation
4 Type-1 Diabetes
5 Weight loss medication
6 Uncontrolled Diabetes type 2 and uncontrolled Hypertension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Blood glucose fasting
2 Lipid profile
3 Hematocrit values
|
day zero and two months after starting trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Blood pressure
2 Waist circumference
3 Body weight
|
Every 15th day after enrollment till time period of 2 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2017 |
| Date of Study Completion (India) |
19/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objectives of the Study: To assess the efficacy of Unani personalized programme in the prevention of non-communicable diseases specifically cardiovascular diseases and Diabetes Mellitus-type 2.Unani personalized programme was more effective in reducing body weight,waist circumference and blood pressure at 60th day as compared to standard control drugs. |