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临床试验/CTRI/2024/09/074129
CTRI/2024/09/074129尚未招募2/3 期

A Randomised Controlled Trial To Evaluate The Effect Of Ashwagandhadi Lepa In The Management Of Parikartika (Fissure in ano)

Dr Ravendra Kumar Tiwari1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Complete healing of the parikartika vrana (Fissure wound)

研究概览

简要总结

One of the most prevalent anorectal diseases, Fissure in ano, is caused by a longitudinal tear in the anoderm beneath the dentate line. In this condition defecation is painful, and there is a streak of bleeding on the stool. It affects both males and females equally and is common in all age groups. Most of the fissures heal by conservative means but a significant proportion turn chronic, negatively impacting a patient’s overall quality of life. It has been reported that the yearly incidence is 1.1 per 1000 persons, which translates to a 7.8% lifetime risk1. Most patients with fissures are middle-aged or younger, with a mean onset of 39.9 years2. Anal fissure incidence is seen to be rather high in Chennai due to the hot climate and a diversified diet. According to studies done at the Government Medical College Tirunelveli Tamil Nadu on patients with anorectal diseases who were chosen at random, 30.7% had anal fissures3. The treatment options for chronic fissures are generally based on reducing the anal pressures and include non-surgical and surgical modalities. Out of the various treatment modalities available, need for a simple, cost-effective, non-invasive treatment should be adopted which goes with day to day life of the patient. In the conventional method to reduce pain, such as a sitz bath, topical anesthetics, steroids, and analgesics are used as supporting measures. Surgical treatments such as Lords Anal dilatations, posterior sphincterotomy5, fissurotomy6, lateral internal sphincterotomy 7, excision of the anal canal, and anal advancement of the flap8 often produce practical difficulties for the patient. External Applications such as Ropana taila, Pichu, Matra Basti, Varti, Ksharakarma, Kshara sutra and Lepa are explained. Ashwagandhadi Lepa is one of the such modality which has the property of healing the Vrana9. The main ingredients of Ashwagandhadi lepa are Ashwagandha, Katuki, Lodhra, Katphala, Madhuyashti, Manjistha & Flowers of Dhataki.

Previous research work done by “Sikandan A, Shinomiya T, Nagahara Y(2018), Division of Life Science and Engineering, School of Science and Engineering, Tokyo Denki University, Hatoyama, Japan.

Ashwagandha root extract exerts anti-inflammatory effects in HaCaT cells and regulating cytokines, International journal of molecular medicine.” This study reveals the anti-inflammatory activity of Ash-wex

on the skin, by using the human keratinocyte cell line HaCaT. The result indicates that Ash-wex significantly works on anti-inflammation and ulcer healing10.

Most of the ingredients of Ashwagandhadi lepam have anti-inflammatory, analgesic, and ulcer-healing properties. More over compared to modern modalities it is cost-effective, non-irritant, easily available, and convenient medicine. Goghritam has Madhur Rasa, Guru, Snigdha, Mridu Guna, Sheeta Veerya, VataPittaharam11, and Vrana Ropana properties12.So, There is the need to evaluate the effect of Ashwagandhadi Lepa with Ghrita (Trial Drug) and compare with Jatyadi Ghrita (as the standard of care) and as an external application in Fissure in Ano along with Triphala Churnam as a common laxative for both groups.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subjects diagnosed with the clinical sign and symptoms of Parikartika.

排除标准

  • Known cases of inflammatory bowel diseases, Severe anal stenosis, Patients diagnosed with malignancy, Patients diagnosed with AIDS, Hepatitis B.

结局指标

主要结局

Complete healing of the parikartika vrana (Fissure wound)

时间窗: 15 days

次要结局

  • Complete healing of the Fissure wound without any complications.(After completion of the study and wound healing (vrana), patients will be advised to follow up in 30 and 45 days.)

研究者

发起方
Dr Ravendra Kumar Tiwari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ravendra Kumar Tiwari

Sri Jayendra Saraswathi Ayurveda College and hospital chennai ,Tamilnadu

研究点 (1)

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