| CTRI Number |
CTRI/2022/09/045383 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
09/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the efficacy of two unani formulations in deranged lipid levels |
|
Scientific Title of Study
|
A Randomized Open Study to Compare the Efficacy of Two Unani Formulations in the Management of Dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayeedur Rahman |
| Designation |
PG scholar department of moalajat |
| Affiliation |
Ajmal khan Tibbiya college Aligarh Muslim university Aligarh |
| Address |
Department of moalajat ajmal khan Tibbiya college Aligarh Muslim university Aligarh
Department of moalajat ajmal khan Tibbiya college Aligarh Muslim university Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9870906771 |
| Fax |
|
| Email |
sayeedkhanalig@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr mursaleen Naseer |
| Designation |
Assistant professor |
| Affiliation |
Ajmal khan Tibbiya college Aligarh Muslim university Aligarh |
| Address |
Department of moalajat ajmal khan Tibbiya college Aligarh Muslim university Aligarh
Department of moalajat ajmal khan Tibbiya college Aligarh Muslim university Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412562724 |
| Fax |
|
| Email |
drmursaleen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sayeedur Rahman |
| Designation |
PG scholar department of moalajat |
| Affiliation |
Ajmal khan Tibbiya college Aligarh Muslim university Aligarh |
| Address |
Department of moalajat ajmal khan Tibbiya college Aligarh Muslim university Aligarh
Department of moalajat ajmal khan Tibbiya college Aligarh Muslim university Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9870906771 |
| Fax |
|
| Email |
sayeedkhanalig@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of moalajat ajmal khan tibbiya college Aligarh Muslim university aligarh 202002 |
|
|
Primary Sponsor
|
| Name |
Department of moalajat Ajmal khan Tibbiya college Aligarh Muslim university Aligarh |
| Address |
Department of moalajat ajmal khan Tibbiya college Aligarh Muslim university Aligarh 202002 |
| Type of Sponsor |
Government 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 |
| Sayeedur Rahman |
Ajmal khan tibbiya college hospital |
Ajmal khan Tibbiya college
Aligarh
UTTAR PRADESH |
09870906771
sayeedkhanalig@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 |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lipotab |
Drug will be gien 2 tab at bed time orally for 90 days |
| Intervention |
Safoof-e- kundur |
drug will be given 6 grams orally twice a day for 90 days ater food
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A) Patients between 30-60 years of age, both male and female
B) Patient ready to participate in the study and ready to follow the instructions
Subjective criteria:
a) Increased body weight
b) Dyspnea on exertion
c) Fatigue
d) Xanthelasma
e) Xanthoma
f) Corneal arcus
Objective criteria
Lipid profile:
Serum cholesterol: 200-300mg/dl Serum triglycerides: 200-300mg/dl Serum HDL: 30-50 mg/dl Serum LDL: 100-150 mg/dl Serum VLDL: 30-50 mg/dl BMI: 25-30kg/m2 |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
A) Pregnacy and lactation
B) Diabetic patient having HBAlc>8 % and FBS >250 mg /dl
C) Diabetes mellitus with complications like Diabetic ketoacidosis, retinopathy, Nephropathy, CHD, CVD etc
D) Several liver and renal diseases E) Severe systemic illnesses
F) Patient who failed to follow up. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in following objective criteria
Lipid profile:
Serum cholesterol:200-300mg/dl Serum triglycerides:200-300mg/dl
Serum HDL: 30-50 mg/dl Serum LDL: 100-150 mg/dl Serum VLDL: 30-50 mg/dl
BMI:
25-30kg/m2 |
Three months with fortnightly follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective criteria such as
Dyspea
Xanthoma
Xanthelasma
Corneal arcus
|
Three months with fortnighly follwup |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2022 |
| 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="0"
Months="1"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dyslipidemia is the disease in which there is derrangement of lipid metabolism.. There are various drugs used to treat this condition. But i am want try to find out a holistic medicine for this condition.. Due to above reason I selected this topicvfor my research work |