跳至主要内容
临床试验/CTRI/2025/07/090050
CTRI/2025/07/090050尚未招募Phase 3 4

A randomized controlled clinical study to evaluate the efficacy of haridradi lepa in the managment of agantuja shopha (superficial thrombophlebitis)

Dr Shreeraksha R C1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
reduction of pain tenderness swelling and local raised temperature and after application of haridradi lepa

研究概览

简要总结

Superficial Thrombophlebitis is a common inflammatory thrombotic disorder in which a thrombus develops in a vein located near the surface of the skin, Most superficial veins that develop thrombosis also have phlebitis.1 Phlebitis is an inflammation of the vessel wall and it manifest as localized pain, redness, swelling and palpable venous cord.2The incidence rate of intravenous catheter placement in a patient admitted to hospital is about 50%3, the most common complication associated with peripheral intravenous catheter insertion is phlebitis with reported incidence ranges from 25-59%4.

Acharya Sushruta has mentioned Agantuja Shopha in Sutrasthana 17th chapter Amapakweshaniya Adhyaya5, caused by external trauma with pitta and rakta vitiation. External trauma due to IV cannula may lead to Superficial Thrombophlebitis which has symptoms as that of Inflammatory swelling, this can be correlated to Agantuja Shopha.

The existing treatment for superficial thrombophlebitis caused by intravenous (IV) catheters is application of THROMBOPHOB OINTMENT which reduces the signs of inflammation but it has its own side effects such as abnormal blue discolouration of skin, reddish discolouration of skin, burning sensation6, numbness, skin itching and Urticaria7.

In Sharangadhara Samhita Uttarakhanda 11th chapter, HARIDRADI LEPA is mentioned as Agantuka raktaja shothagna lepa8, it can be used as a ayurvedic line of management in case of Agantuja shopha as it includes the drugs which have shothaghna, raktaprasadana, vedanaharana and raktashodaka, varnya, dahaghna, property which helps to reduce the signs of inflammation such as swelling, erythema, pain, local raised temperature9. Hence an attempt is made to evaluate the efficacy of Haridradi lepa with Thrombophob ointment in Agantuja Shopha (Superficial Thrombophlebitis).

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
10.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Clinical signs and symptom of Superficial Venous Thrombophlebitis 2)Established cases of Superficial Venous Thrombosis due to IV canulization in upper limbs.

排除标准

  • HIV and HbsAg positive patients 2)Cases of Deep Vein Thrombosis 3)Subjects under immunosuppresants 4)Patients on anti-coagulants bleeding disorders (thrombocytopenia hemophilia) 5) Uncontrolled Diabetic Mellitus(greater than250mg per dl).

结局指标

主要结局

reduction of pain tenderness swelling and local raised temperature and after application of haridradi lepa

时间窗: 21 days

次要结局

  • thrombophob ointment is more effective than haridradi lepa(21 days)

研究者

发起方
Dr Shreeraksha R C
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shreeraksha R C

Shree jagadguru gavisiddeshwar ayurvedic medical college and hospital koppal

研究点 (1)

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