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CTRI Number  CTRI/2025/10/096736 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 28/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case series 
Study Design  Other 
Public Title of Study   Ayurvedic management of primary chronic venous disease 
Scientific Title of Study   Case Series to evaluate the efficacy of Tab. Arjuna (Terminalia arjuna (Roxb.) Wight & Arn.) in combination with Siravyadha (Therapeutic Phlebotomy) in improving clinical outcomes and quality of life in primary chronic venous disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Room No. 621, Dept of Ayurveda, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
Cheruthuruthy, Thrissur
Palakkad
KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Room No. 621, Dept of Ayurveda, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
Cheruthuruthy, Thrissur

KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Room No. 621, Dept of Ayurveda, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
Cheruthuruthy, Thrissur

KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Source of Monetary or Material Support  
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur, Kerala - 679531, India  
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Janakpuri, D Block. New Delhi 
Type of Sponsor  Research institution 
 
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 KM Pratap Shankar  National Ayurveda Research Institute for Panchakarma  Room 621, Dept of Ayurveda, Hospital Division, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy
Thrissur
KERALA 
9744824014

kmpvarma@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee,National Ayurveda Research Institute for Panchakarma  Approved 
Institutional Ethics Committee  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 ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: , Procedure details: )
2Intervention ArmDrugClassical(1) Medicine Name: Tab Arjuna, Reference: Bhavaprakasha Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants of either sex with primary CVD with grades C4–C6 on the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification.
2. Participants capable of and freely willing to provide written informed consent prior to participating in the study and comply with the study protocol requirements.

 
 
ExclusionCriteria 
Details  1. Participants with vascular disease other than CVD, moderate and severe anemia, neurological, dermatological, and orthopedic disorders (that may mimic venous symptoms).
2. Participants with lower limb oedema due to cardiac, renal or hepatic diseases or participants with lower limb arterial disease.
3. Smokers, concomitant or previous history of addiction to alcohol or drug abuse, pregnant women, lactating women, and those who have undergone vein surgery recently.
4. Participants with clinically significant renal disease, hepatic disease, cardiovascular disease, psychological diseases (anxiety, depression etc.), and participants on medications hampering skin healing.
5. Participants in whom there will be a likelihood of being lost for follow-up or moving out of the state within the trial period.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Venous Clinical Severity Score (VCSS)   Baseline, Day 30, Day 60 & Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in quality of life (QoL) assessed by Global Index Score (GIS) calculated through Chronic Venous Insufficiency Questionnaire (CIVIQ-20) questionnaire   Baseline & Day 90 
Duration of symptom-free period: Duration of symptom-free period after cessation of the 3-month intervention. The patient will be observed for 3 months to determine if further standard care is required, such as compression stockings or additional sessions of Siravyadha  180th day 
Any type of mild, moderate, and severe adverse events during the study period will be recorded.   90 days 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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 4 
Date of First Enrollment (India)   12/11/2025 
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="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Chronic venous disease or CVD is one of the most common vascular disorders observed across the globe and can severely impact quality of life, reduce the individual’s working hours, and impose a socioeconomic burden. CVD typically refers to telangiectases or spider veins, reticular veins, varicose veins, lower extremity edema, skin trophic changes, and ulceration secondary to ambulatory venous hypertension, which is caused by venous valve reflux, venous flow obstruction, or both. Several epidemiological studies have reported that CVD is a progressive condition. If CVD is left untreated, it results in a gradual loss of cosmesis and a variety of complications, the major ones being persistent pain and discomfort, hemorrhage, superficial thrombophlebitis, and progressive skin changes that may ultimately lead to ulceration.The goal of CVD treatment focuses on decompressing the sources of increased venous pressure. If the superficial saphenous vein is involved, then there are several types of surgical procedures to manage CVD. If the deep venous system is involved, compression stockings are used. Compression therapy is the standard of care for patients with advanced CVD and venous ulcers. Still, compliance rates are poor due to multiple reasons, including physical discomfort, difficulty in application, cost, and psychological factors. Advanced treatments include surgery like vein stripping, ultrasound-guided foam sclerotherapy, radiofrequency, and laser ablation. Risks and complications of all these procedures include perforation, DVT, pulmonary embolism, phlebitis, hematoma, infection, skin burns, and nerve injury.
The pathological stages of CVD have been evaluated with a range of pathological conditions in Ayurveda, such as Siragranthi, Raktavaritavata, Apana Vaigunya, Arsha, Vatarakta, Kushtha, and Dushta Vrana, depending upon the presentations of the patient.Siravyadha or Therapeutic phlebotomy, one of the Panchasodhana or five purificatory therapies, is a specialized procedure aimed at eliminating dushtarakta vitiated blood or accumulated by venous stasis. The procedure is specifically indicated for the various pathological stages of CVD. Further, the procedure reduces venous congestion and stasis, and thereby reduces venous hypertension. An RCT and a pre post trial conducted to study the efficacy of Siravyadha in CVD have reported a reduction in the severity of CVD assessed through Venous Clinical Severity Score and improved the quality of life of CVD patients.Arjuna  or Terminalia arjuna is a potential drug that has pharmacological actions on the circulatory system. According to Bhava Prakasha, Arjuna is considered Hridyam or beneficial for the heart and circulatory system, supporting circulatory activities and aiding in wound healing. Contemporary researchers have explored it as a potential drug having pharmacological action on reducing venous edema, venous hypertension, and venous hypoxia. The drug also has the potential to reverse vascular remodelling, and the vasoactive constituents considerably influence endothelial well-being and remarkably improve overall venous health. A prospective observational study conducted by the investigator on 25 patients or 31 limbs of CVD treated with Tab Arjuna 500mg BD found that there was a six point difference in the median VCSS score on the 90th day of both limbs compared to baseline. Hence, it is proposed that the combination of the interventions will enhance the venous sufficiency by decreasing the venous hypertension and venous stasis and thereby eventually reduce the disease severity of advanced stages of CVD.   
 
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