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临床试验/CTRI/2025/12/098505
CTRI/2025/12/098505尚未招募不适用

A Single Arm Clinical Study to evaluate the efficacy of Shigrumooladi lepa in the management of raktarsha with special reference to 1st and 2nd degree hemorrhoids.

Jeevan Jyoti Ayurvedic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12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
30
试验地点
1
主要终点
Reduction in per-rectal bleeding (Raktasrava).

研究概览

简要总结

Arsha, described in Ayurvedic classics as Mamsankura formation in the Gudamarga causing obstruction and producing pain like an enemy, closely resembles hemorrhoids. Hemorrhoids are characterized by dilatation of the hemorrhoidal venous plexus and displacement of the anal cushions, presenting with bleeding, swelling, discomfort, and constipation. They are among the most prevalent anorectal disorders, affecting nearly half of the population by the age of 50, and pose a significant global health burden. Conventional management includes rubber band ligation, sclerotherapy, and infrared coagulation, particularly for Grade I–II hemorrhoids; however, these procedures may cause recurrence or complications.

Ayurveda considers Arsha as a Tridoshaja Vyadhi, with both Shushka and Sravi varieties described based on clinical presentation. Classical texts highlight several formulations possessing Arshoghna properties. Shigrumooladi Lepa, containing Shigrumoola Twak, Arka Patra, and Aja Mutra, demonstrates Katu, Tikta, and Kashaya Rasa contributing to Kaphashamana and Raktastambhana. Its Ushna Veerya and Katu Vipaka facilitate Amapachana, Agnideepana, and reduction of local congestion.

Considering the need for safe, cost-effective, and non-invasive treatment options, the present study aims to evaluate the clinical efficacy of Shigrumooladi Lepa in the management of 1st and 2nd degree hemorrhoids. This research intends to provide scientific evidence supporting its therapeutic benefits and contribute to integrative anorectal care.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • DIAGNOSED PATIENTS OF RAKTASRAVA-ANAL BLEED PATIENTS OF EITHER SEX PATIENTS WITH CONTROLLED HYPERTENSION AND DIABETES MELLITUS FRESH OR PREVIOUSLY OPERATED PAINFULL OR PAINLESS.

排除标准

  • Patients suffering from Bleeding disorders like-Anal polyp ,prolapsed rectum ,Ulcerative colitis ,Crohn’s Disease ,Carcinoma of rectum and anus .
  • Infectious diseases like HIV ,HbsAg ,HCV Pregnant and lactating women Incontinence of stool Bleeding diathesis.

结局指标

主要结局

Reduction in per-rectal bleeding (Raktasrava).

时间窗: 4 weeks

次要结局

  • Improvement in quality of life (QoL) Reduction in associated symptoms such as constipation, pruritus ano,etc(4 weeks)

研究者

发起方
Jeevan Jyoti Ayurvedic Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vijender Kumar

Jeevan Jyoti Ayurvedic Medical College and Hospital,Aligarh

研究点 (1)

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