| CTRI Number |
CTRI/2025/08/092937 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Testing Euphorbia prostrata for patients with Chronic Vein Disease: Does It Reduce Symptoms and Improve Daily Life? |
|
Scientific Title of Study
|
Efficacy and safety of euphorbia prostrata in the management of chronic venous disease: a randomized controlled 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 AP Rohith |
| Designation |
Full Time Research Scholar |
| Affiliation |
Srm Institute of Science and Technology |
| Address |
Room no. 4, 4th floor, Department of Pharmacy Practice, SRM Medical College Hospital and Research Centre, SRM Nagar, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9710574178 |
| Fax |
|
| Email |
aprohith2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. M.G.Rajanandh |
| Designation |
Professor |
| Affiliation |
Srm Institute of Science and Technology |
| Address |
Room no. 4, 4th floor, Department of Pharmacy Practice, SRM Medical College Hospital and Research Centre, SRM Nagar, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598464723 |
| Fax |
|
| Email |
mgr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr AP Rohith |
| Designation |
Full Time Research Scholar |
| Affiliation |
Srm Institute of Science and Technology |
| Address |
Room no. 4, 4th floor, Department of Pharmacy Practice, SRM Medical College Hospital and Research Centre, SRM Nagar, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9710574178 |
| Fax |
|
| Email |
aprohith2001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. A.P. Rohith |
| Address |
Room no. 4, 4th floor, Department of Pharmacy Practice, SRM Medical College and Hospital. SRM Nagar, Kattankulathur. |
| Type of Sponsor |
Other [Self Funded for Phd Study ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rohith AP |
SRM Medical College Hospital and Research Centre |
Room no 4, Ground Floor, Department of General Surgery, SRM Medical College Hospital and Research Centre, SRM Nagar, Kattankulathur.
Kancheepuram
TAMIL NADU |
9710574179
aprohith2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Euphorbia Prostrata |
Drug Name: Euphorbia prostrata
Dose: 100-200 mg extract Route: Oral Frequency: Twice daily Duration: 7-14 days (acute), 4-12 weeks (chronic) Purpose: Treats hemorrhoids & venous insufficiency via anti-inflammatory and venotonic effects. |
| Comparator Agent |
Tablet Pilex |
Drug Name: Pilex (Polyherbal Formulation)
Dose: 1 Tablet (650 mg)
Route: Oral Administration
Frequency: Twice Daily (Every 12 Hours)
Duration: 12 Weeks (84 Days) Treatment Period
Purpose: Management of Grade I-II Hemorrhoids and Mild Chronic Venous Insufficiency through anti-inflammatory, venotonic and astringent properties. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 65 years with clinically diagnosed primary varicose veins CEAP C2 to C4.
Symptomatic patients presenting with pain, swelling, pigmentation, or skin changes.
Eligible for treatment with Euphorbia prostrata, Pilex or surgery.
Willing to provide informed consent and comply with follow up visits for 24 weeks. |
|
| ExclusionCriteria |
| Details |
Diagnosis of secondary varicose veins, including cases related to deep vein thrombosis, trauma or congenital venous anomalies.
Presence of active venous ulcers CEAP class C5 to C6 or infective dermatitis at the study entry.
Known systemic conditions such as hepatic impairment, renal dysfunction, coagulopathies, or uncontrolled diabetes.
Pregnancy, lactation or known allergy to study medications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain scores (VAS scale)
Decrease in bleeding episodes (hemorrhoids)
Improvement in heaviness/aching (varicose veins)
Objective Clinical Measures
Reduction in hemorrhoid size (proctoscopy grading)
Improvement in venous refill time (Doppler ultrasound)
Decrease in visible varicosity severity (CEAP classification)
|
Baseline visit (Day 1)
Day 90 (plus or minus 3 days)
Final visit at Day 180 (plus or minus 3 days) - End of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Metabolic & Systemic Parameters
BMI, waist circumference
Lipid profile (HDL, triglycerides)
Glycemic control (HbA1c, fasting glucose)
Blood pressure (systolic/diastolic)
Liver Safety Profile
AST, ALT, ALP, bilirubin levels
Patient-Reported Outcomes
Quality of life score (disease-specific questionnaire)
Number of adverse events |
Baseline visit (Day 1)
Day 30 (plus or minus 3 days)
Day 60 (plus or minus 3 days) - Telephonic follow-up
Day 90 (plus or minus 3 days)
Day 135 (plus or minus 3 days) - Telephonic follow-up
Final visit at Day 180 (plus or minus 3 days) - End of study |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
25/08/2025 |
| 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="11"
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
|
This research aims to evaluate the efficacy and safety of Euphorbia prostarta extract compared to Pilex and surgical intreventions in 300 patients with Chronic venous disease (CVD), including varicose veins and hemorrhoids. Conducted over 24 months at SRM Medical College Hospital, The study will randomize participants into three equal groups (n=100 each) using block randommization. Primary outcomes include improvement in venous reflux (Duplex Ultasonography) and hemorrhoid severity metabolic markers, quality of life (civiq-20), and safety (CBC, LFT, RFT). Assesments will occur at baseline, weeks 12 and 24, with interim telephonic followups. the study adressses a gap in robust evidence for herbal therapies in chronic venous disease and complies with ICH-GCP and ICMR ethical guidelines. |