跳至主要内容
临床试验/CTRI/2025/04/084217
CTRI/2025/04/084217尚未招募1/2 期

Evaluation Of comparative efficacy of newly developed Kinshuk gel versus active control compound (Heparin Sodium plus Benzyl Nicotinate in the management of Thrombophlebitis (Sira Granthi Vikar) (RCT)

Dr Mansi Nakum1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Kinshuk gel is as equally efficacious as Standard Compound in the management of Thrombophlebitis sira granthi vikar

研究概览

简要总结

Thrombophlebitis is defined1 as formation of blood clot inside the vein resulting inflammation of adjacent tissue of wall. it Also known as phlebothrombosis or venous thrombosis.1 Pathophysiological causes include presence of a thrombus in the lumen of a superficial vein, followed by Inflammatory reaction of its wall and adjacent tissue. It precedes thrombophlebitis is initiated by triad of changes: endothelial damage, alteration in the composition of blood and venous stasis. It represents as swelling, tenderness, redness etc. there is bruises, blood clot under the skin also may be seen. in 1856 Virchow identified three predisposing factors – slowing of blood stream, changes in blood vessel wall, changes in blood itself. Also called as Virchow’s Triad Those who are immobile after surgery, obese, having varicose veins etc. it happens by trauma to vein. With various external injury or internal factors. Here the major cause of superficial thrombophlebitis is by venous injury like intra venous catheter, intra venous injection etc. there are 3 types of phlebitis mainly mechanical, chemical, infectious. Mechanical thrombophlebitis occurs when peripheral IV catheter not secured properly leading tissue damage. In Chemical phlebitis occur by irritants like drugs, infectious thrombophlebitis produced when using contaminated catheter during Iv insertion. Among them there is 30% cases 2 involving IV cannula linked thrombophlebitis. Thrombophlebitis migrates in which multiple thrombus appears in superficial vein and although deeper can be involved. Some other factor like secondary infection, bacteremia etc. in which circulating organism settle in intima of vein and produce phlebitis with secondary thrombosis. Here the major cause ofsuperficial thrombophlebitis is by venous injury like intra venous catheter, intra venous injection etc. For superficial thrombophlebitis topical Heparin is used with Benzyle nicotinate topically for 7 days duration. 2 In view of ayurveda thrombophlebitis can be corelate with siragat vikar, As siragranthi 3. Sira granthi explained by Aacharya Sushrut in Nidan sthan as type of granthi. Which is caused by vatadi dosha dushti, mamsa and asruk dushti. In samprapti bhedan vyayam aadi nidan sevan cause vat dushti which cause sirapratan, sira sampidan, sira sankoch, sira vishoshan and in results vrut & aashu sira granthi appears. Sira is updhatu of rakta dhatu. Sira genesis done by essence part of rakta dhatu. In thrombophlebitis there is raktavaha dushti and siragat vikar. In correlation blood clot may be shonit sanghat in sira.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Patient willing with written informed consent as per Helsinki declaration.
  • Age group of 17 to 70 years.
  • Patients with clinical features of thrombophlebitis (swelling , redness , pain , warmth) 4) Patients irrespective of gender, occupation and economic status.

排除标准

  • Phlebitis caused by Malignancy, Septicemia, deep vein thrombosis or with pus formation 2) Uncontrolled and insulin dependent Diabetes Mellitus, Uncontrolled Hypertension , Tuberculosis, Carcinoma Endocrine Disorders and Kidney or hepatic disorder.
  • Sites of thrombophlebitis – sensitive places like : genitals, eye lids, lips Pregnant and lactating females.

结局指标

主要结局

Kinshuk gel is as equally efficacious as Standard Compound in the management of Thrombophlebitis sira granthi vikar

时间窗: 1 week

次要结局

  • Decreases swelling pain tenderness(Decreases swelling pain tenderness)
  • Decrease pain swelling tenderness clot dissolve(7days)

研究者

发起方
Dr Mansi Nakum
申办方类型
Other [dr. mansi nakum]
责任方
Principal Investigator
主要研究者

Mansi Nakum

Mahatma gandhi ayurved college salod wardha datta meghe higher education and research center

研究点 (1)

Loading locations...

相似试验