CTRI Number |
CTRI/2021/12/038818 [Registered on: 21/12/2021] Trial Registered Prospectively |
Last Modified On: |
22/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Medical Device Ayurveda Diagnostic Screening |
Study Design |
Other |
Public Title of Study
|
Difference between kulatta gutika with atrovastatin in the treatment of dislipidemia |
Scientific Title of Study
|
Comparative Evaluation of Efficacy of Kulattha Gutika with Atorvastatin in the Management of Dyslipidemia (Medoroga) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Praveen Nandal |
Designation |
pg scholar |
Affiliation |
datta meghe institute of medical science |
Address |
room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha Wardha MAHARASHTRA 442001 India |
Phone |
9813075320 |
Fax |
|
Email |
praveennandal320@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sadhana Misar wajpeyi |
Designation |
Professor |
Affiliation |
datta meghe institute of medical sciences |
Address |
room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha Wardha MAHARASHTRA 442001 India |
Phone |
9763732083 |
Fax |
|
Email |
sadhanamisar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sadhana Misar wajpeyi |
Designation |
Professor |
Affiliation |
datta meghe institute of medical sciences |
Address |
room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre hirapur salod wardha
MAHARASHTRA 442001 India |
Phone |
9763732083 |
Fax |
|
Email |
sadhanamisar@gmail.com |
|
Source of Monetary or Material Support
|
Mahatma gandhi ayurved college hospital and research center |
|
Primary Sponsor
|
Name |
Mahatma gandhi ayurved college hospital and research center |
Address |
salod hirapur wardha |
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 |
Dr Praveen Nandal |
Mahatma gandhi ayurved college hospital and research center |
Room no 30 department kayachikista Mahatma gandhi ayurved college hospital and research center Wardha MAHARASHTRA |
9813075320
praveennandal320@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Mahatma gandhi ayurved college hospital and research center institutional ethics committee salod wardha |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kulttha gutika, Reference: bhavparkash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: | 2 | Comparator Arm (Non Ayurveda) | | - | Atrovastatin | 10 mg HS for 45 days |
|
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients willing to participate in the study
Age between 30 to 60 years of either sex
Subjects fulfilling the following diagnostic criteria of Dyslipidemia
Diagnostic Criteria Serum Total Cholesterol less than or equal to 200 mg per dl and or
Serum Triglycerides equal to 150 to 499 mg per dl and or Serum HDL Cholesterol less than 40 mg per dl and or Serum LDL Cholesterol equal to 130 to 189 mg per dl |
|
ExclusionCriteria |
Details |
Pre diagnosed cases of major illness like cardiovascular disorder diabetes mellitus and renal disorders
Patients taking the medication like glucocorticoids
During pregnancy and lactation period in women
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
To assess efficacy of Kulattha Gutika in Total cholesterol Triglyceride HDL LDL VLDL and BMI |
45 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study the incidence of dyslipidemia as per prakruti corelation with medo roga |
before treatment |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
01/01/2022 |
Date of Study Completion (India) |
01/04/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per comport generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups. The trial is a parallel-group, randomized, single-blind, standard - controlled trial. It will include, a 45 days treatment period, and a 15th, 30th 45th day week follow-up period. |