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临床试验/CTRI/2025/05/087256
CTRI/2025/05/087256尚未招募不适用

Effect of Shukti Bhasma Pratisaran/Avachurnan to stop Capillary haemorrhage & Venous haemorrhage in any external haemorrhagic conditions in comparison with Hemocoagulase enzyme topical solution (Botroclot) in the age group of 10 to 80 yrs

DMM Ayurved Mahavidyalaya,Yavatmal1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
The clotting time will be noted after the dusting of Shukti Bhasma a 2mm thick

研究概览

简要总结

This study is randomized trail comparing the efficacy and safety of shukti bhsasma and haemocoagulase  solution for haemostasis of capillary and venous haemorrhage in 35 patients of each group that will be conducted in India.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
10.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.The patients have any external capillary or venous haemorrhage from wounds resulting due to surgery or trauma on the whole body 2.Patients with ongoing antiplatelet or anticoagulant therapy like aspirin, clopidogrel, warfarin and heparin will also be included.
  • 3.Patients irrespective of gender, religion, marital status and socioeconomic class will be selected 4.Patients who will give their consent to participate.

排除标准

  • The patients pre-diagnosed with bleeding disorders such as Haemophilia or Von Willebrand disease, sickle cell disease, anaemia (Hb less than 8gm), thrombocytopenia, who require BT, who have just received BT.
  • who need emergency surgical care and shock will be excluded.
  • Patients with arterial bleeding or associated arterial bleeding.
  • Patients with other systemic diseases such as AIDS, HBsAg, TB, Uncon trolled Diabetes, Uncontrolled Hypertension, Malignancy, Leprosy and STDs.
  • Dagdha Vrana.
  • Ulcers with no bleeding.
  • Patients with wounds due to any animal or insect bite.
  • Pregnant and lactating mother.
  • Patients with addictions specifically alcohol, tobacco & smoking.

结局指标

主要结局

The clotting time will be noted after the dusting of Shukti Bhasma a 2mm thick

时间窗: every minute for the first 10 min then | every 2 min for the next 10 min & then every 5 min till 30 min after 1hr, 6hrs, | 24hrs, 48hrs. After 48hrs if there is no bleeding follow-up will be taken after 1 | week.

layer over the bleeding site.

时间窗: every minute for the first 10 min then | every 2 min for the next 10 min & then every 5 min till 30 min after 1hr, 6hrs, | 24hrs, 48hrs. After 48hrs if there is no bleeding follow-up will be taken after 1 | week.

次要结局

  • Apart from haemostasis, other effects like discoloura(tion, burning, tingling and warmth at the site of bleeding will be assessed.)

研究者

发起方
DMM Ayurved Mahavidyalaya,Yavatmal
申办方类型
Other [Research Institution and Hospital]

研究点 (1)

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