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临床试验/CTRI/2020/12/030064
CTRI/2020/12/030064已完成2 期

Efficacy of Jaloukavacharana and Kasisadi Taila in the management of Sirajanya Vrana [Venous Leg Ulcer] – An open labelled randomized comparative clinical trial

Institute for PostGraduate teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Changes in signs and symptoms of Sirajanya Vrana (Venous Leg ulcer)

研究概览

简要总结

The research study entitled "Efficacy of Jaloukavacharana and Kasisadi Taila in the management of Sirajanya vrana (Venous Leg Ulcers) – An open labelled randomised comparative clinical trial" has been completed and is summarized below.

After screening 67 cases of non-healing ulcers, 31 cases were falling under the inclusion criteria as well as diagnostic criteria. All 31 cases were consented and enrolled for the study from which, 7 cases were dropped out and 24 cases completed the course of treatment and follow up as mentioned in the synopsis of the study.

Effect of the therapy

Highly significant effect was observed in Group A therapy in Vedana, Kandu and early granulation. Significant effect was seen in Daha, and Srava. Significant reduction in size of the ulcer was seen in Group A patients. Significant results were observed in CT value while no significant results were observed in other parameters like Hb, Total leukocyte count, Eosinophils, Monocytes, Basophils, ESR, BT and RBS. Significant effect of therapy was observed in relieving Vedana, Daha, Kandu and early granulationin patients of Group B. Non-significant effects were observed in reduction of size of the ulcer after therapy though clinically considerable changes were observed in the patients. Significant results were observed in the neutrophils, lymphocytes and BT values. Insignificant effect was observed in parameters like Hb, Total leukocyte count, Eosinophils, Monocytes, Basophils, ESR, CT and RBS. In the comparative effect of therapy, statistically no significant differences were found in the effects of therapy on both the groups, ie, Group A (Jaloukavacharana and Kasisadi taila)and Group B (Kasisadi taila local application) in the management of Venous Leg Ulcer, though clinically better evident outcomes were seen in individual patients of Group A, i.e., Jaloukavacharana followed by Kasisadi taila local application.

Jaloukavacharana followed by Kasisadi taila local application was found to be effective against single isolate bacteria specifically gram-negative bacteria such as Escherichia coli, Pseudomonas aeruginosa along with mixed isolates Escherichia coli+ Pseudomonas aeruginosa by Day 10 of therapy. Kasisadi taila was found to be ineffective against single isolatesEscherichia coli and Enterobacter species till Day 30 of therapy and effective against mixed isolates Escherichia coli+ Pseudomonas aeruginosa by Day 30.

Overall result of therapy

Maximum patients i.e., 41.67% and 25% got complete relief in Group A and Group B from the clinical condition of Venous Leg Ulcer respectively. 50% and 25 % patients got marked improvement in their condition from Group A and Group B respectively while 8.33% and 50% patients got moderate improvement from Group A and Group B respectively.

On the basis of the clinical study, observations and results, discussion was written on the review of literature, observations, effect of therapies, mode of action of therapies and anti-microbial effects of the medicine.

The study concluded that Jaloukavacharana and Kasisadi taila shows similar wound healing effect in the management of Sirajanya vrana (Venous Leg Ulcer).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 Diagnosed Cases of Venous Leg Ulcer/Ulcers with chronicity of above 15 days 2 Controlled cases of Type 2 Diabetes Mellitus (RBS ≤180mg/dL) 3 Controlled cases of Hypertension (BP ≤ 160/90).

排除标准

  • 1 Malignant ulcers, tubercular ulcers, syphilitic ulcers 2 Patients of Malignancy of any organ 3 Uncontrolled cases of Hypertension (BP >160/90) 4 Uncontrolled cases of Type 1 and Type 2 Diabetes Mellitus (RBS >180mg/dL).
  • •Heart diseases like MI, CAD, IHD.
  • •Patients having embolism, bleeding disorder, arterial occlusion disease and other infective skin disorders.
  • •Patients with immune-compromised diseases like HIV, HbsAg, Cancer, HCV.
  • •Sarvanga sopha (Swelling all over the body) •Panduroga (Pallor/Anemia), Arsha (Haemorrhoids),Udara(Ascites),Sosha (Cachexia), Garbhini (Pregnant woman).

结局指标

主要结局

Changes in signs and symptoms of Sirajanya Vrana (Venous Leg ulcer)

时间窗: 4 weeks

次要结局

  • Improvement in quality of life of the person(2 months)

研究者

发起方
Institute for PostGraduate teaching and Research in Ayurveda
申办方类型
Research institution and hospital

研究点 (1)

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