| 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 |
|
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Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Janakpuri, D Block. New Delhi |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I838||Varicose veins of lower extremities with other complications. Ayurveda Condition: SIRAJAGRANTHIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: , Procedure details: )
| | 2 | Intervention Arm | Drug | Classical | | (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.
|
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| 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. |
|
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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
|
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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. |