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临床试验/CTRI/2024/12/078515
CTRI/2024/12/078515尚未招募2 期

A Single arm clinical study to evaluate the wound healing efficacy of Jalaukavacarana in the managemnet of venous ulcer (Dusta Vrana)

J S Ayurveda Mahavidyalaya1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
1. Vedanā (pain)

研究概览

简要总结

Ulcer defined as any break in the continuity of the epithelial tissue. Venous Ulcer is also known as Stasis ulcer. It occurs due to chronic venous insufficiency caused by improper functioning of venous valves of the lower limb. Chronic and prolonged cases of varicose veins yield valve incompetence and stasis of blood resulting in venous hypertension allowing blood protein fibrinogen leakage causing fibrin to build up around vessels and prominence of vein preventing oxygen and nutrients from reaching the cell resulting in ulceration. The overall incidence rate is 0.76% in men and 1.42% in women. Over the age of 65, the prevalence increases to 4%. Among leg ulcers, 75% of ulcers are due to disorders of the venous system. The conservative treatment of venous ulcers includes standard wound dressing, wearing of support stockings and rest with legs elevated whenever possible along with diet and lifestyle modifications, debridement, sterile wound dressing, and at last life-saving aspects i.e., amputation. Wound care has become increasingly important given the rise of non-healing wounds and the morbidity associated with them. But the recurrence rate is quite high, the high recurrence along with severity of symptoms makes it a prominent subject of concern and interest in terms of finding more effective, more convenient, economical modalities of management. SuÅ›ruta Samhitā has exclusively mentioned the treatment regime for ‘Vraṇa’ as Jalaukāvacāraṇa. This study is planned to evaluate the effectiveness of Jalaukāvacāraṇa in wound healing in the patients of venous ulcer*.*

Each of the 20 patients will be treated with Jalaukāvacāraṇa on every 7th day and daily dressing with Jatyadi Taila will be done for 6 weeks along with oral medicaments i.e. Mañjiá¹£thādÄ« Kvātha 40ml twice a day on empty stomach and KaiÅ›ora Guggulu 3 tablet (each of 300mg) with warm water for 10 weeks. Patients may have to come to the hospital for follow up and investigations at every 15th day up to 4 weeks in O.P.D. to record the changes in sign and symptoms of disease.

The changes in the ulcer during the treatment will be observed and assessed by subjective and objective criteria. Subjective criteria includes pain, itching, odour and colour of the ulcer. Objective crieteria includes venous clinical severity score (VCSS) will be assessed before, 2nd, 4th, 6th  and 8th week of the treatment.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient of age between 18 to 60 years and of both the genders.
  • Active venous ulcers.
  • History of recurrence of venous ulcers.
  • Duration of ulcer up to 3 years.
  • Patient having Hb percentage greater than 10 gm/dl
  • Patients with controlled hypertension and diabetes.
  • Patients who fulfill any three symptoms of the above mentioned diagnostic criteria.

排除标准

  • Pregnant or lactating women.
  • Uncontrolled Hypertension and diabetes.
  • Duration of ulcer more than 3 years.
  • Known case of diseases like STDs, TB, heart diseases and other disorders which lead to fatal condition for the patients.
  • Patients having embolism, bleeding disorder, and other infective skin disorders.
  • Patients with immune-compromised diseases like HIV, HbsAg, and HCV etc.
  • Patient having Hemoglobin percentage lower than 10 gm/dl
  • Other types of wounds such as Malignant wound, tuberculous wound, leprosy ulcer, and syphilitic ulcers.

结局指标

主要结局

1. Vedanā (pain)

时间窗: 8 Weeks

To check the efficacy of Jalaukavacharana in the patient of venous ulcer by below given points:

时间窗: 8 Weeks

2. Gandha (Odour of discharge)

时间窗: 8 Weeks

3. Varṇa – (Skin Colour Surrounding Wound)

时间窗: 8 Weeks

4. Kaṇḍu (Itching)

时间窗: 8 Weeks

5. Venous Clinical Severity Score (VCSS)

时间窗: 8 Weeks

6. Wound Measurement

时间窗: 8 Weeks

7. Others

时间窗: 8 Weeks

次要结局

  • To observe the changes in Venous clinical severity score (VCSS)(8 Weeks)

研究者

发起方
J S Ayurveda Mahavidyalaya
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vishal Malviya

J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital

研究点 (1)

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