FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E780||Pure hypercholesterolemia. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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
2Intervention ArmLifestyle--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.

 
Close