Efficacy of Hijama bish shart(wet cupping) in primary varicose vein (Dawali)- A randomized controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- VCSS Score (Revised venous clinical severity score)
研究概览
简要总结
Title of study- Efficacy of Hijama bish shart (wet cupping) in primary varicose vein (Dawali)- A randomized controlled clinical trial
study design-single centre, two armed, parallel groups assessor blinded randomized controlled clinical trial
Intervention- subjects in the test group will undergo 3 sittings of HijÄma bish Shará¹ at regular intervals of 7 days (0 day, 7th day and 14th day) and the last assessment for efficacy done on the 21st day. The wet cupping will be done by following standard operative procedure. One medium-sized (5.2 cm) and one small-sized cup (3 cm) will be applied over the calf region at least 5 cm away from the maximum tortuosity of the most prominent varicose vein. If both calves have varicosities, 2 cups will be applied on each limb. Approximately 10-15 tiny (2mm depth, 2mm length) superficial scarifications will be made at the cupped area and approximately 20 ml of blood will be drawn in medium and 10 ml in small cup and discarded as per NABH guidelines. The values of VCSS will be averaged if varicosities are present in both legs. The vitals of the patients will be recorded before and after the procedure. Compression stockings will be worn by all patients as mentioned in the control group for 21 days.
control group- Compression stockings The elastic compression stocking exerting 20-30 mm Hg of pressure, will be worn daily for 21 days during the daytime (for at least 8 hours) from the ankle to below the knee and removed during the night.
Primary outcome measure- VCSS Score ( Revised venous clinical severity score)
sample size- 36
site of study- National Institute of Unani Medicine, Bangalore
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient clinically diagnosed case of primary varicose vein
- •willing to sign the informed consent form.
排除标准
- •1.patients having grade 2 hypertension 2.patients of secondary varicose vein 3.pregnant and lactating women 4.patients who fail to follow up 5.patients having diabetus mellitus and other systemic illness eg cancer liver ,kidney, cardiac and pulmonary diseases 6.patients with haemoglobin less than 9.5gm/dl 7.patients having bleeding diathesis,HIV infection, hepatits B and C infection
- •patients of deep venous thrombosis.
结局指标
主要结局
VCSS Score (Revised venous clinical severity score)
时间窗: At Baseline, 7th day, 14th day, 21st day
次要结局
- No secondary outcome(Not applicable)
研究者
Dr Budeppa
National Institute of Unani Medicine, Bangalore