CTRI Number |
CTRI/2023/07/055365 [Registered on: 19/07/2023] Trial Registered Prospectively |
Last Modified On: |
18/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
Role OF Guduchyadi Choorna With Madhu Along With Lifestyle Modifications In Dyslipdemia |
Scientific Title of Study
|
Effect Of Guduchyadi Choorna With Madhu As An Adjuvant To Lifestyle Modifications In Dyslipidemia |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anjana R |
Designation |
Pg Scholar Department Of Swasthavritta |
Affiliation |
Government Ayurveda College Thiruvananthapuram |
Address |
Government Ayurveda Panchakarma Hospital Poojappura Thiruvananthapuram
Thiruvananthapuram KERALA 695012 India |
Phone |
8137887568 |
Fax |
|
Email |
bhaskaranjana93@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anjana R |
Designation |
Pg Scholar Department Of Swasthavritta |
Affiliation |
Government Ayurveda College Thiruvananthapuram |
Address |
Government Ayurveda Panchakarma Hospital Poojappura Thiruvananthapuram
Thiruvananthapuram KERALA 695012 India |
Phone |
8137887568 |
Fax |
|
Email |
bhaskaranjana93@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr V K Sunitha |
Designation |
Professor And HOD |
Affiliation |
Government Ayurveda College Thiruvananthapuram |
Address |
Government Ayurveda Panchakarma Hospital Poojappura Thiruvananthapuram
Thiruvananthapuram KERALA 695012 India |
Phone |
9446371393 |
Fax |
|
Email |
drsunithasunilkumar@gmail.com |
|
Source of Monetary or Material Support
|
Government Ayurveda College Thiruvananthapuram |
|
Primary Sponsor
|
Name |
Government Ayurveda College Thiruvananthapuram |
Address |
Anjana.R PG Scholar Government Ayurveda Panchakarma Hospital Poojappura Thiruvananthapuram 695012 |
Type of Sponsor |
Other [Government Ayurveda College Thiruvananthapuram] |
|
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 |
Anjana R |
Government Ayurveda Panchakarma Hospital |
Department Of Swasthavritta Op NO:2 Government Ayurveda Panchakarma Hospital Poojappura Thiruvananthapuram Thiruvananthapuram KERALA |
08137887568
bhaskaranjana93@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee(IEC)Government Ayurveda College Thiruvananthapuram |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E780||Pure hypercholesterolemia. Ayurveda Condition: MEDOROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi choorna, Reference: charaka,sutrasthana,Ashtonindadheeyam adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Guduchyadi choorna contain Guduchi,Triphal,Musta | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Brisk walking for 30 minitues and diet for 45 days, Pathya/Apathya:yes, Pathya:, Apathya: |
|
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Serum total cholesterol between 200mg/dl-239mg/dl
2.on ATP guidelines having LDL between 130mg/dl-159mg/dl
3.triglycerides 150mg/dl-199mg/dl
4.HbA1c below 7% |
|
ExclusionCriteria |
Details |
1.Known case of coronary Artery Disease
2.Known case of Thyroid and Renal disorders
3.Pregnant women and lactating women
4.Participants under any medication of dyslipidemia
5.Insulin dependent diabetic patients |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1 Changes in Serum Total Cholesterol
2 Changes in LDL cholesterol
3 Changes in Triglycerides
4 HbA1C |
0th,46th, 90th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
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
|
Phase 3 |
Date of First Enrollment (India)
|
26/07/2023 |
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
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Dyslipidemia is
either one or a combination of elevated total cholesterol, high LDL-C , low HDL-C, and elevated triglyceride . Dyslipidemia is a
major risk factor for coronary heart disease (CHD) . People with dyslipidemia
are at a twofold increased risk of developing CVD as compared to those with
normal lipid levels . CVD is becoming more prevalent globally and is one of the
prominent causes of death . Raised levels of certain lipids in the blood
increase the risk of atherosclerosis, which is recognized as the primary risk
factor for stroke, peripheral vascular, and CHD . Most (80%) of the lipid disorders are
associated with diet and lifestyle . Modifiable risk factors, including a diet
high in saturated or trans fats, sedentary lifestyle, smoking, and obesity
increase the risk of dyslipidemia . The prevalence of dyslipidemia is much
higher among patients with coexisting cardiovascular risk factors such as
hypertension, diabetes, or human immunodeficiency virus.According to World
Health Organisation(WHO) estimate in 2008 ,the prevalence of
dyslipedemia(defined as blood levels of TC190mg/dl)in the southeast Asia is
30.3%, in Europe 53.7% and in America 47.7%. The prevalence of dyslipedemia is
very high in India also according to ICMR-INDIAB study,13.9% had hypercholestrolemia,29.5%
had hypertriglyceridemia,72.3% had low HDL-C, 11.8% had high LDL-C levels and
79% had abnormalities in one of the lipid parameters.Many interventional trials
reported to have hypolipidemic effect which give rapid temporary relief but
cause long term side effects1. Herbals has much potential in
preventing lifestyle problems because of minimal
adverse effects.Clinical importance of herbal drugs in the management of
dyslipidemis has received considerable attention in recent years.The study
aimed to explore the efficacy of Guduchyadi choornam with madhu along with Lifestyle modification in
dyslipidemia.In ayurveda ,it can be better correlated with
medodushti,associated with kaphadosa and dhatwagni mandhya,which is a
functional condition and just a precursor stage of medoroga and can be easily
reversible by effective regimen. Treatment of stoulya can be adopted for
dyslipedemia which includes
kapha , medohara ,deepana, pachana ,rukshana and lekhana karmas.The
study aimed to explore the efficacy of guduchi, triphala
and musta with madhu along with lifestyle modification in dyslipidemia.All the
mentioned drugs have the property mentioned above.
A Quaziexperimental study will be performed in 60 patients of both
sex,satisfying inclusion and exclusion criteria .Out of 60 patients , 30 each
will be allocated to Intervention group
(group 1) and Comparison group (Group2).The patients in the group 1 will be instructed
to consume 6gm of Guduchyadi
choorna with 12gm of madhu as
anupana before food in morning and evening along with lifestyle modification
such as diet restrictions and exercise. Life style modification alone will be
advised to comparison group.The study period is fixed for 45 consequetive days.The
serum lipid profile will be analyzed before study and on 46th day and follow up will be done after the study period for 45 days .The data collected will be processed and conclusions will be made accordingly. |