CLINICAL STUDY ON EFFECTIVENESS OF JALAUKAVACHARANA IN THE MANAGEMENT OFVATARAKTA (BUERGERâ€™s DISEASE)

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital1 site in 1 country30 target enrollmentStarted: January 3, 2016Last updated: July 2, 2018

Conditions

Trial Snapshot

Phase: Phase 2
Status: Recruiting
Sponsor
Enrollment: 30
Locations: 1
Primary Endpoint: subjective parameters

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

In Vatarakta Vata and Rakta obstruct movements of each other because of Avarana, so Raktamoshana(blood letting) is indicated to clear the channels and free movements of Vata and Rakta.

Jalaukavacharana(leech therapy) one among Raktamokshana treatment is taken as treatment modality because Jalaukavacharana relives symptoms like different types of pain, burning sensation.it is also said that Jalaukavacharana is indicated in conditions where Rakta is clotted and deep seated.

Aims and Objectives of the study

To evaluate the efficacy of Jalaukavacharana in the management of Vatarakta (Buergerâ€™s disease)

Methedology

Current study is open labeled, single arm, prospective clinical study with minimum 30 patients with pre and post test design.

patient will be screened with the screening form which will be prepared with all aspects of history, sign and symptoms of Vatarakta(buergerâ€™s disease), laboratory investigations to rule out major illness. After screening the patients of Vatarakta(buergerâ€™s disease), will be recruited into the study.

Jalaukavacharana will be done once in 2 days for 3sittings.(1st ,4th and 6th day)

Total duration of treatment 7days.

JAKAUKAVACHARANA:.(leech therapy)

Â· Purva Karma(pre op procedure)

Â· For patientThe patient is made either to sit or lie down, the area selected for application of Jalauka made rough by rubbing with either mud or fine powder of cow dung without causing pain.

Â· **For Jalauka(leech)**the body of Jalauka should be smeared with solution of paste of Sarsapa and Haridra and kept in a water pot for a period of one Muhurta(28 minutes), the after knowing that they are free from fatigue it should be picked up and made to catch the place of the disease.

Â· Pradhana Karma(operative procedure)

Jalauka is to be applied on the site. Jalauka will bite on the skin and suck the blood itself. Its face appears like the hoof of a horse and it raises its neck by this we can understand that it has started sucking blood. As soon as Jalauka starts sucking, wet white gauze will be covered on it

Â· Paschat Karma**(post op procedure)**

After sucking Shuddha Rakta(pure blood) patient gets itching and pain at the site, then it is removed by sprinkling Haridra churna(turmeric powder ) at its mouth region and dressing will be done

Follow up

After completion of 3 sitting of Jalaukavacharana patients will be reviewed again.

Study Design

Study Type: Interventional
Allocation: Not Applicable
Masking: Open Label

Eligibility Criteria

Ages: 16.00 Year(s) to 45.00 Year(s) (—)
Sex: Male

Inclusion Criteria

•1.Smoking index (SI) > 300 [No. of cigarettes smoked per day x No. Of years of smoking] 2.Pack years index (PYI) >40 [ No. of years of smoking x No of packets of cigarettes per day] 3.Shiyanoyaâ€™s criteria for T.A.O Tobacco use, only in males Disease starts before 45 years.
•Distal extremities involved first without embolic or atherosclerotic features.
•Absence of diabetes mellitus or hyperlipidaemia.
•With or without thrombophlebitis.
•Patient who are ready to participate and sig n the informed consent form.

Exclusion Criteria

•Cases of diabetes mellitus with peripheral neuropathies, cardiac diseases, bleeding disorders, thrombocytopenia, any other severe systemic diseases.
•Chronic ulcers due to varicose veins.