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Clinical Trials/CTRI/2025/01/078849
CTRI/2025/01/078849Not yet recruitingPhase 2

A Comparative Clinical Study Of Jalaukavacharna With And Without Local Application Of Mahavajraka Tail In The Management Of Sirajgranthi W.S.R To Varicose Veins

Dayanand Ayurvedic College1 site in 1 country60 target enrollmentStarted: February 5, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Following symptoms will be assessed for the reduction in their severity:

Study Overview

Brief Summary

The total of 60 patients will be selected who are between age group of 18 to 65 years of either sex who are diagnosed with Sirajgranthi on the basis of sign and symptoms. Patients will be divided into two groups (Trial Group A and Trial Group B). Group A will be intervene with Jalaukavcharna and Group B will be intervene with Jalaukavcharna along with local application of Mahavajraka Tail and conduct a clinical study - To evaluate the efficacy of Jalaukavcharna in the   management of Sirajgranthi w.s.r to Varicose Veins,To evaluate the efficacy of Jalaukavcharna along with local application of Mahavajraka Tail in the management of Sirajgranthi w.s.r to Varicose Veins, To evaluate the difference of efficacy of Jalaukavcharna with and without local application of Mahavajraka Tail in the management of Sirajgranthi w.s.r to Varicose Veins.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subjects with classical signs and symptoms of Sirajgranthi.
  • Subjects between 18 years to 65 years.
  • Any gender willing and able to participate in the study.

Exclusion Criteria

  • Subjects having chronicity more than 10 years.
  • Pregnant women and lactating women will be excluded.
  • Subjects having any other major complicated diseases like Diabetes Mellitus, Cardiac Diseases, Tuberculosis, HIV, HCV, HBsAg.
  • Subjects diagnosed with Venous Ulcers, Deep Vein Thrombosis, Anemia, Thrombocytopenia will be excluded.

Outcomes

Primary Outcomes

Following symptoms will be assessed for the reduction in their severity:

Time Frame: On Day - 0, 10th, 20th, 30th and 45th Day.

1. Shoola (Pain in Lower Limbs)

Time Frame: On Day - 0, 10th, 20th, 30th and 45th Day.

2. Kandu (Itching)

Time Frame: On Day - 0, 10th, 20th, 30th and 45th Day.

3. Daha (Burning Sensation)

Time Frame: On Day - 0, 10th, 20th, 30th and 45th Day.

4. Shotha (Oedema)

Time Frame: On Day - 0, 10th, 20th, 30th and 45th Day.

5. Sirakunchana (Tortuosity of Veins)

Time Frame: On Day - 0, 10th, 20th, 30th and 45th Day.

6. Skin Changes

Time Frame: On Day - 0, 10th, 20th, 30th and 45th Day.

Secondary Outcomes

  • Significant Improvement in the objective parameters.(On Day - 0, 10th, 20th, 30th and 45th Day.)

Investigators

Sponsor
Dayanand Ayurvedic College
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Rohit

Dayanand Ayurvedic College

Study Sites (1)

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