| CTRI Number |
CTRI/2025/01/078859 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Unani Treatment for Metabolic syndrome |
|
Scientific Title of Study
|
Efficacy of Arq-e-Zeera and Qurs-e-Tabasheer in the Secondary Prevention of Metabolic Syndrome: An Open Intervention Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ahamed Shifak Fathima Shifra |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Tahaffuzi wa Samaji Tib, National Institute of Unani
Medicine, kottigepalya, Magadi Main Road, bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8618133697 |
| Fax |
|
| Email |
fathimashifra@fim.cmb.ac.lk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arish Mohammad Khan Sherwani |
| Designation |
Professor and HOD |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Tahaffuzi wa Samaji Tib, National Institute of Unani
Medicine, kottigepalya, Magadi Main Road, Bangaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9448794691 |
| Fax |
|
| Email |
arish_sherwani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ahamed Shifak Fathima Shifra |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Tahaffuzi wa Samaji Tib, National Institute of Unani
Medicine, kottigepalya, Magadi Main Road, Bangaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8618133697 |
| Fax |
|
| Email |
fathimashifra@fim.cmb.ac.lk |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru-560091, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangaluru-560091, Karnataka, India |
| Type of Sponsor |
Other [National Institute for Researches, Prevention and Cure in Unani System of Medicine] |
|
|
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 Ahamed Shifak Fathima Shifra |
Hospital of National Institute of Unani Medicine, Bengaluru |
Department of
Tahaffuzi wa Samaji tib,
National Institute of
Unani Medicine,
Kottigepalya, Magadi
Main Road, Bengaluru.
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8618133697
fathimashifra@fim.cmb.ac.lk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Unani Medicine Communication of Decision of the Institutional Ethics Committee for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Unani formulations of Arq-e-Zeera and Qurs-e-Tabasheer |
75 ml of Arq-e-Zeera twice a day before meals and 3 Tablets of Qurs-e- Tabasheer twice a day after meals for 60 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All gender
Patients between 20 to 60 years of age
BMI of 18.50 to 34.99 kg/m2
Patients with three or more out of the five components of Metabolic syndrome by IDF & AHA/NHLBI (2009) criteria
Patients having normal to moderate degrees of those morbidities or co-morbidities
Patients on medications for Diabetes mellitus Type 2
Patients on medications for Hypertension
|
|
| ExclusionCriteria |
| Details |
Unstable, bedridden, mentally retarded, and with serious illness
Pregnant and lactating mothers
Uncontrolled Diabetes Mellitus Type 2 (FBG more or equal 200mmHG, PPBS more or equal 300mmHG )
Uncontrolled Hypertension (SBP more than 159 mmHg and DBP more than 99 mmHg)
Patients not willing to give written consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms and investigations |
Intervention Period 60 days and outcome will be assessed on 60th day. Baseline and 60th day examinations will be analyzed.
Enrolment Period 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
The metabolic syndrome (MetS) consists of a constellation of metabolic abnormalities that confer an increased risk of cardiovascular disease (CVD) and diabetes mellitus and it has gained significant interest worldwide due to its escalating prevalence, which places a heavy burden on the global healthcare system. According to IDF & AHA/NHLBI (2009) criteria, A person to be diagnosed with MetS, he/she should have 3 or more of the 5 components of MetS. They are: central obesity, hypertriglyceridemia, low HDL-C, hypertension and hyperglycemia.
The MetS hasn’t been described in Unani classical literature. But, according to Unani physicians, the key risk factors of MetS i.e. diabetes mellitus, obesity, high blood pressure and abnormal blood lipids have been described separately as different disease conditions. There are several single and compound drugs have been mentioned in Unani classical texts to treat each component of MetS separately. But as a syndrome its components vary from person to person. Therefore it is aimed to select Arq- e-Zeera and Qurs-e- Tabasheer in combination to evaluate their combined effect in the secondary prevention of Metabolic syndrome.
Clinically known and newly diagnosed cases of MetS, if fulfilling selection criteria will be selected and enrolled after obtaining written informed consent. Subjects will be administered with 75 ml of Arq-e-Zeera twice a day before meals and 3 Tablets of Qurs-e-Tabasheer twice a day after meals for 60 days. Followup will be done on 0th, 15th, 30th, 45th and 60th days. Baseline examination and 60th day examination will be analyzed statistically. The data on objective parameters will be recorded in a specialized case report form (CRF). Outcome of the study will be compared with the findings of baseline and after completion of the study.
|