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临床试验/CTRI/2018/02/011872
CTRI/2018/02/011872招募中2 期

CLINICAL STUDY ON EFFECTIVENESS OF JALAUKAVACHARANA IN THE MANAGEMENT OFVATARAKTA (BUERGER’s DISEASE)

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1月3日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
subjective parameters

研究概览

简要总结

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 (Buerger’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(buerger’s disease), laboratory  investigations to rule out major illness. After screening the patients of Vatarakta(buerger’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)

·         Purva Karma(pre op procedure)

·         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.

·         **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.

·         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

·     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.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
16.00 Year(s) 至 45.00 Year(s)(—)
性别
Male

入选标准

  • •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.Shiyanoya’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.

排除标准

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

结局指标

主要结局

subjective parameters

时间窗: After completion of eaach 3 sittings of Jalaukavacharana i.e .1st ,4th and 6th day patients will be reviewed again.

Pain

时间窗: After completion of eaach 3 sittings of Jalaukavacharana i.e .1st ,4th and 6th day patients will be reviewed again.

Burning sensation

时间窗: After completion of eaach 3 sittings of Jalaukavacharana i.e .1st ,4th and 6th day patients will be reviewed again.

Sleep

时间窗: After completion of eaach 3 sittings of Jalaukavacharana i.e .1st ,4th and 6th day patients will be reviewed again.

Walking ability

时间窗: After completion of eaach 3 sittings of Jalaukavacharana i.e .1st ,4th and 6th day patients will be reviewed again.

Ulceration

时间窗: After completion of eaach 3 sittings of Jalaukavacharana i.e .1st ,4th and 6th day patients will be reviewed again.

次要结局

  • Pallor (Buerger’s test)(Boyd’s classification for intermittent)

研究者

发起方
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
申办方类型
Research institution and hospital

研究点 (1)

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