跳至主要内容
临床试验/CTRI/2024/05/067835
CTRI/2024/05/067835已完成2/3 期

Efficacy of local application of Rohini Taila and Thumari Taila in the management of Sirajanya Vrana (Venous Ulcer) – An open labelled randomized controlled clinical trial.

Institute of teaching and research in Ayurveda Jamnagar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月17日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
•Healing of Sirajanya Vrana (Venous Ulcer).

研究概览

简要总结

Over a 30-day clinical study, the efficacy of Rohini Taila and Thumari Taila was evaluated in the management of Sirajanya Vrana (Venous Leg Ulcer). Both formulations possess Ropana (healing), Shodhana (cleansing), anti-inflammatory, and antibacterial properties, which promote granulation tissue formation, epithelialization, collagen synthesis, and wound contraction, as supported by Ayurvedic and modern scientific principles. Kanchanar Guggulu was administered as an adjuvant to enhance venous circulation and systemic healing.Demographic observations revealed a higher incidence of Sirajanya Vrana among elderly males with sedentary lifestyles and lower socioeconomic backgrounds. Clinically, most ulcers were chronic or recurrent, presenting with pain, itching, exudation, and occasional burning sensations. Both treatment groups showed a marked reduction in pain, burning, itching, exudates, microbial load, and wound size.Although complete remission was not achieved in all cases, the majority of patients exhibited moderate to remarkable improvement. The study concludes that Rohini Taila and Thumari Taila are effective in promoting wound healing, alleviating symptoms, and enhancing patient comfort. These findings advocate the integration of traditional Ayurvedic approaches with contemporary wound-care concepts in the management of chronic venous ulcers.


研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • The patient presented with Sirajanya Vrana (Venous Ulcer) as 2 or more clinical features of diagnostic criteria of venous ulcer & diagnosed cases of Sirajanya Vrana (Venous Leg Ulcer/Ulcers).
  • Patient of Sirajanya Vrana (Venous Ulcer), age group of
  • 70 years, irrespective of gender, caste, religion and socioeconomic status.
  • Patient with/without HTN (BP less than 140/90mm/Hg) and DM (RBS less than150 mg/dl) with medication.

排除标准

  • Patients having DVT (Deep Vein Thrombosis), embolism, bleeding disorders, arterial occlusion disease and other infective skin disorders.
  • Known case of cardiac diseases, malignancy, tubercular ulcers & known case of immune- suppressive disease.
  • Patient with/without HTN (BP greater than 140/90mm/Hg) and DM (RBS greater than 150 mg/dl) with medication.

结局指标

主要结局

•Healing of Sirajanya Vrana (Venous Ulcer).

时间窗: 30 day

•Reduce in pain, odor of discharge and itching ,improvement in skin colour surrounding the wound.

时间窗: 30 day

次要结局

  • Absence of recurrence in the follow period(Day 45 and day 60)

研究者

发起方
Institute of teaching and research in Ayurveda Jamnagar
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Poonam Choudhari

Institute of teaching and research in Ayurveda

研究点 (1)

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