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CTRI Number  CTRI/2026/03/105184 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 02/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study to assess effect of selected Ayurvedic Treatment protocol on Metabolic syndrome ( Condition with Dyslipidemia, elevated FBS, elevated Blood pressure and higher waist circumference) 
Scientific Title of Study   Effect of Selected Ayurvedic Treatment Protocol on HOMA IR Level in Metabolic Syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kowsalya Devi R T 
Designation  Second Year PG Scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Kayachikitsa Government Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9061690391  
Fax    
Email  kowsalyanavamani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Asha Karunakaran K 
Designation  Associate Professor 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kayachikitsa Government Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9447023308  
Fax    
Email  ashkvrindavan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Asha Karunakaran K 
Designation  Associate Professor 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kayachikitsa Government Ayurveda College Thiruvananthapuram


KERALA
695001
India 
Phone  9447023308  
Fax    
Email  ashkvrindavan@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College, Thiruvananthapuram 695001 
 
Primary Sponsor  
Name  Government Ayurveda College 
Address  Government Ayurveda College Thiruvananthapuram Kerala PIN 695001 
Type of Sponsor  Other [Government Ayurveda College] 
 
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 
Kowsalya Devi R T  Government Ayurveda College, Thiruvananthapuram  OP No 2 Department of Kayachikitsa Government Ayurveda College Thiruvananthapuram Kerala PIN 695001
Thiruvananthapuram
KERALA 		 9061690391

kowsalyanavamani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda College Thiruvananthapuram Kerala PIN 695001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Chiruvilwadi Kashayam , Reference: Sahasrayoga Arshas prakarana, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Vaiswanara Choorna, Reference: Astangahridaya Gulma Chikitsa Adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: with Kashayam
3Intervention ArmProcedure-udvartanam, उद्वर्तनम् (Procedure Reference: Astangahridaya Dinacharya, Procedure details: For 35 mins/daily)
(1) Medicine Name: Triphala Choornam, Reference: Astangahridaya Sutrasthana Annaswaroopa Vigjnaniyam, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Duration: 7 Days
4Intervention ArmDrugClassical(1) Medicine Name: Khadira asana bhavitha triphala choorna capsules, Reference: Chikitsa Manjeri Sthoulya chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 23 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Identified with MetS according to HARMONIZED CRITERIA 2009
HOMA IR Level greater than 1 
 
ExclusionCriteria 
Details  Who are known case of myocardial infarction, chronic liver disease,neoplasm and CKD
Pregnant and lactating mothers
HbA1c greater than or equal to 9 percentage 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HOMA IR level  Baseline,8th Day and 31st Day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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)   12/03/2026 
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 Yet Recruiting 
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   The above study deals with assessing the effect of a selected ayurvedic treatment protocol in metabolic syndrome. It is a interventional single arm pre post study design. Evaluation is made on changes in HOMA IR level. 
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