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CTRI Number  CTRI/2023/05/052460 [Registered on: 10/05/2023] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study to Evaluate the Efficacy of Guduchyadi yoga in Medoroga With Special Reference to Dyslipidemia 
Scientific Title of Study   A Randomized Open-Labelled Controlled Clinical Study to Evaluate The Efficacy of Guduchyadi yoga In The Management Of Medoroga With Special Reference to Dyslipidemia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amrutha Y 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Room Number 304, Department of PG Studies in Kayachikitsa, Sri Sri College of Ayuervedic Science and Research, 21st KM Kanakapura Road, Udayapura Post Bengaluru, Bengaluru Rural-560082, Karnataka

Bangalore
KARNATAKA
560082
India 
Phone  8197391854  
Fax    
Email  amrutha.y156@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neelakanta J Sajjanar 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Room Number 304, Department of PG Studies in Kayachikitsa, Sri Sri College of Ayuervedic Science and Research, 21st KM Kanakapura Road, Udayapura Post Bengaluru, Bengaluru Rural-560082, Karnataka

Bangalore Rural
KARNATAKA
560082
India 
Phone  8147891325  
Fax    
Email  neelkant.ayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amrutha Y 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Room Number 304, Department of PG Studies in Kayachikitsa, Sri Sri College of Ayuervedic Science and Research, 21st KM Kanakapura Road, Udayapura Post Bengaluru, Bengaluru Rural-560082, Karnataka

Bangalore
KARNATAKA
560082
India 
Phone  8197391854  
Fax    
Email  amrutha.y156@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research 
 
Primary Sponsor  
Name  Dr Amrutha Y 
Address  Room Number 304, Department of PG Studies in Kayachikitsa, Sri Sri College of Ayuervedic Science and Research, 21st KM Kanakapura Road, Udayapura Post Bengaluru, Bengaluru Rural-560082, Karnataka 
Type of Sponsor  Other [Self] 
 
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 
Dr Amrutha Y  Sri Sri College of Ayurvedic Science and Research  Room Number 304, Department of PG Studies in Kayachikitsa, Sri Sri College of Ayuervedic Science and Research, 21st KM Kanakapura Road, Udayapura Post Bengaluru, Bengaluru Rural-560082, Karnataka
Bangalore Rural
KARNATAKA 		 8197391854

amrutha.y156@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri sri institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Navaka guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Guduchyadi Yoga, Reference: Vangasena Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -1.5g Guggulu), Additional Information: -Ingridents- 1. Guduchi 2. Triphala 3. Guggulu
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects who fulfill the diagnostic criteria-
subjects will be diagnosed based on serum lipid profile- with increased levels of any of the serum lipids-

Total cholesterol >200mg/dL
LDL >129mg/dL
Triglycerides ≥150mg/dL
HDL ≤40mg/dL
VLDL ≥30mg/dL

2. Both Obese and non-obese subjects will be included. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women.
2. Subjects with any uncontrolled systemic illness including Diabetes Mellitus and Hypertension.
3. Subjects who are on any medication for Dyslipidemia.
4. Subjects with any other condition interfering with the course of disease and treatment.
5. Subjects with any of the following Serum Lipid Levels-
Total cholesterol >400mg/dL
LDL >189mg/dL
Triglycerides >400mg/dL
HDL >40mg/dL
VLDL >100mg/dL
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Serum Lipid Levels  0th day
30th day
45th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2023 
Date of Study Completion (India) 10/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Amrutha Y, Sajjanar J Neelkant, Krishna Gopala. Efficacy of Guduchyadi Yoga in the Management of Medoroga with special reference to Dyslipidemia- A Rondomized Clinical Trial. International Journal of Ayurveda and Pharma Research. 2025;13(2):1-7. https://doi.org/10.47070/ijapr.v13i1.3549 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The study, “A randomized controlled parallel group clinical study to evaluate the efficacy of Guduchyadi yoga in the management of Medoroga w.s.r to Dyslipidemia” was undertaken to manage Dyslipidemia through Ayurveda as it has a high prevalence all over world and in India. It is also identified as a potential risk factor for many life-threatening diseases like ischemic heart disease and stroke.

The dissertation was made into two parts. The initial part of the dissertation deals with review of literature comprising of Nirukthi, Paribhasha, Nidana, Roopa and Chikitsa of Medoroga. It also includes incidence of dyslipidemia, lipid metabolism, classification, clinical feature and Management of Dyslipidemia. The later part includes materials and methods, observation, result, discussion on observation and results, conclusion and summary.

The trial was registered prospectively in CTRI on 10/05/2023 with CTRI number: CTRI/2023/05/052460. The present study was completed with 30 subjects in 2 groups- Trial group (Group A) and Control group (Group B). Each Group had 15 subjects selected randomly. Subjects in Group A were treated Guduchyadi yoga. Coarse powders of Guduchi, Triphala, along with shodhita purana guggulu, was procured from GMP Certifies Pharmacy. 24g of kwatha churna was added to 400ml of water and boiled in open vessel until it was reduced to 50ml, to this 1.5 grams of shodhita purana guggulu was added to prepare Guduchyadi Yoga. Subjects in group B were treated with Navaka guggulu which was procured from GMP certified pharmacy.

The interventions were administered for a span of 30 days. Assessment       was done on 0th day, 30th day and 45th day. Assessment was done on basis of objective parameters. Objective parameters were serum lipid levels. Additionally, efficacy on weight and BMI of the subjects were also assessed.

Statistical analysis for the above parameters was done using the Unpaired t-test, Repeated measures of ANOVA, Paired t-test, Mann Whitney U Test, Friedman test, and Wilcoxon Sign rank test.

On comparing the results between the groups showed statistically non-significant results on majority of parameters suggesting that, both Guduchyadi churna and Navaka guggulu had equal effect in the management of medoroga.

However, based on effect size, oral administration of the trial drug Guduchyadi Yoga is more efficacious than the control drug Navaka Guggulu in the management of Dyslipidemia.


 
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