A Comparative clinical study of Dashanga lepa and Dhatura lepa in the management of vranashopha (cellulitis).
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical efficacy of Dashang lepa vs Dhatura lepa in the management of Vranshopha ( cellulitis)
研究概览
简要总结
This randomized comparative clinical study aims to evaluate and compare the efficacy of two classical Ayurvedic formulations—Dashanga Lepa and Dhatura Lepa—in the management of Vranashopha (Cellulitis). Vranashopha, described in Ayurvedic texts, resembles modern cellulitis, an inflammatory swelling of soft tissue commonly caused by bacterial infection.
A total of 60 patients (age group: 12–60 years) diagnosed with cellulitis on the extremities, and meeting inclusion criteria, will be enrolled from the OPD/IPD of the Department of Shalya Tantra at Ashwin Rural Ayurved College and Hospital, Sangamner.
Participants will be randomized into two groups:
Group A: Local application of Dashanga Lepa
Group B: Local application of Dhatura Lepa
The Lepa will be applied once daily for 6 days, and patients will be assessed on Day 0, 2, 4, and 6 for changes in symptoms such as pain, swelling, itching, warmth, and redness. Laboratory parameters such as Hb%, TLC, neutrophil count, ESR, and serum creatinine will also be monitored.
The primary objective is to assess which formulation is more effective in reducing symptoms of Vranashopha. Secondary outcomes include laboratory changes, safety, tolerability, and overall clinical improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age Range: Individuals aged between 12 and 60 years, inclusive.
- •Diagnosis: Clinically diagnosed cases of Vranashopha (Cellulitis) based on classical Ayurvedic and modern parameters.
- •Location of Lesion: Lesions must be located on the extremities (upper or lower limbs).
- •Size of Lesion: Patients with lesion size ranging from 5 cm to 15 cm in diameter (measured with measuring tape or scale).
- •Willingness and Compliance: Participants must be able and willing to attend regular follow-up visits as per study schedule (Days 0, 2, 4, 6).
- •Must be willing to follow the treatment regimen, including local application of Lepa.
- •Informed Consent: Participants (or legal guardians for minors aged 12–17 years) must be willing and able to provide written informed consent in a language they understand.
排除标准
- •Septicemia: Patients presenting with septicemia or systemic signs of infection requiring emergency care.
- •Surgical Intervention Needed: Patients who require surgical debridement of the wound.
- •Uncontrolled Diabetes Mellitus: Patients with uncontrolled blood glucose levels or known cases of poorly managed diabetes.
- •Immunocompromised Status: Patients with HIV/AIDS or other immunosuppressive conditions.
- •Patients currently undergoing immunosuppressive therapy.
- •Allergy or Hypersensitivity to Dhatura: Known hypersensitivity, allergy, or adverse reactions to Dhatura or any ingredients of the lepa.
- •Chronic or Complicated Ulcers/Wounds: Tubercular ulcers Venous ulcers Malignant ulcers Non-healing wounds (e.g., varicose ulcers) Kshatavrana (traumatic wounds) with complications such as fractures or marmaghat (vital organ injury)
- •Other Conditions: Known cases of Hepatitis B or Hepatitis C.
结局指标
主要结局
Clinical efficacy of Dashang lepa vs Dhatura lepa in the management of Vranshopha ( cellulitis)
时间窗: Day 0 – Baseline (before treatment starts) | Day 2 – First follow-up | Day 4 – Second follow-up | Day 6 – Final assessment (end of treatment period)
次要结局
- Overall clinical improvement and reduction in subjective and objective symptoms(0,2 ,4, 6 days)
- Hematological and biochemical changes and time to noticeable symptom relief in pain , swelling, redness and itching .(0 ,2 , 4 , 6 days)
- Safty , tolerability and adverse reaction of dashang and dhatura lepa(0, 2, 4, 6 days)
- Patient satisfaction / Compliance with subjective feedback regarding comfort ease of application and perceived improvement.(0, 2, 4, 6, days)
研究者
VdVaibhav hari pagore
Ashwin Rural Ayurved College & Hospital manchi hill sangmner ahemadnagar