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CTRI Number  CTRI/2026/02/105031 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 26/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study on the effect of selected Ayurveda treatment protocol in Varicose veins 
Scientific Title of Study   Effect of selected Ayurveda treatment protocol in Varicose veins : A single arm clinical trial 
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 Subi N H 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Shalyatantra Government Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9495881390  
Fax    
Email  drsubironish@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subi N H 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Shalyatantra Government Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9495881390  
Fax    
Email  drsubironish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Haritha P V 
Designation  PG Scholar 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Shalyatantra Government Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9847230464  
Fax    
Email  harithapv007@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Haritha P V 
Address  Government Ayurveda College Thiruvananthapuram Kerala PIN 695001 
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 
Haritha P V  Government Ayurveda College Thiruvananthapuram  OP Division Room No 3 Department of Shalyatantra Government Ayurveda College Thiruvananthapuram Kerala PIN 695001
Thiruvananthapuram
KERALA 		 9847230464

harithapv007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS 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:I838||Varicose veins of lower extremities with other complications. Ayurveda Condition: SIRAJAGRANTHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Sahacharadi Kashyam, Reference: Ashtanga Hridaya Chikitsa sthana ,Vatavyadhi chikitsa prakarana , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 35 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Kaisora Guggulu , Reference: Bhaishajya Ratnavali, Vatarakta adikaram, Route: Oral, Dosage Form: Guggulu , Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 35 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: -
(3) Medicine Name: Sahacharadi Sevya Thailam, Reference: Ashtanga Hridaya Chikitsa sthana ,Vatavyadhi chikitsa prakarana , Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 35 Days, anupAna/sahapAna: Yes(details: Kashaya), Additional Information: -
(4) Medicine Name: Sahacharadi Thailam , Reference: Ashtanga Hridaya Chikitsa sthana Vatavyadhi chikitsa prakarana, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 35 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Ashtangahridayam Sutrasthanam Siravedhavidhi adhyaya, Procedure details: Siravedha will be done on 28th day Amount of blood withdrawn will be 100-200 ml )
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  C4-C5 of CEAP Classification of Varicose veins  
 
ExclusionCriteria 
Details  Participants with bleeding disorders
Participants with Anaemia
Participants testing positive for HIV HCV HBsAg VDRL
Participants with uncontrolled DM and HTN
Pregnant and lactating mothers
Those who are contraindicated for siravedha 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Venous Clinical Severity Score  Assessment will be done on 0th 14th 28th and 35th day 
 
Secondary Outcome  
Outcome  TimePoints 
Venous Blood Gas Analysis  Assessment will be done 0th & 35th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   18/03/2026 
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 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   The study is designed as a pre and post interventional study without a control group involving a sample size of 40 participants. Participants between the age group of 40 to 60 years irrespective of gender having Varicose veins satisfying inclusion and exclusion criteria will be consecutively selected from the OPD and IPD Dept. of Shalyatantra Govt. Ayurveda College Thiruvananthapuram. The treatment protocol includes internal administration of Sahacharadi Kashaya Kaisora Guggulu Tablet Sahacharadi Sevya Thailam and external application of Sahacharadi Thailam for a period of 35 days along with Siravedha done on 28th day. Assessment will be done by Venous Clinical Severity Score on 0th,14th, 28th and 35th day, and Venous Blood Gas analysis on 0th and 35th day. The findings will be recorded and the result will be statistically analysed according to the nature of data using Paired t test or Wilcoxon Signed Rank test. 
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