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临床试验/CTRI/2024/07/071129
CTRI/2024/07/071129尚未招募不适用

A Randomized Comparative Clinical Trial to evaluate the efficacy of Kajjalikodaya Malahara Pichu and Jatyadi Ghrita Pichu in the management of Parikartika with special reference to Acute Fissure-in-Ano.

BVVS Ayurved Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月12日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduction in pain,burning sensation,bleeding per rectum and constipation

研究概览

简要总结

Parikartika is one among the ano-rectal disorders and is one of the complications of Basti and Virechana Karma as mentioned in classics. Parikartika is characterized by Kartanavat and Chedanavat Shoola, Daha in Guda. associated with Vibhanda, Anilasanga and Nabheradhorujam. It is caused by Sthana Samshraya of vitiated Vata and Pitta Doshas in *Gudapradesha.*It can be correlated with fissure-in-ano of the contemporary science.

Anal fissure is longitudinal split in anoderm of the distal anal canal, which extends from the anal verge proximally towards but not beyond the dentate line.It is characterized by severe pain and burning sensation during and after defecation, severe constipation, and there is a drop of blood or streak of fresh blood on stool.

Fissure-in-ano occurs most commonly in midline posteriorly, in males usually posteriorly 95%, anteriorly 5%, and in females posteriorly 80%, and anteriorly 20%. About 30–40% of the population suffers from proctologic pathologies at least once in their lives, in that anal fissure comprises of 10–15%. It occurs equally in both men and women and is common in all age group especially age group of 15-40 years. The incident is supposed to be high in one who passes hard and dry stool.

The line of management in contemporary science is said to be conservative treatment and surgical intervention. The conservative treatment includes analgesics, stool softeners, soothing ointments and anal dilatation where as surgical intervention includes Lord’s dilation, posterior fissurectomy and lateral anal sphincterotomy.

In the Chikitsa of Parikartika, Acharyas have mentioned Madhura, Kashaya Rasa, Sneha Yukta Dravyasin the form of Pichu, Varti and Lepa which pacifies Vata and Pitta Doshas.

Parikartika is considered as Sadyovrana, Acharya Sushruta has mentioned Pichu Prayoga in the context of Shashti Upakrama in the management of Vrana. Pichu is a treatment modality in which drug delivery increases by the contact time between the tissue and drug and as it increases the bioavailability of drug, Hence there will be early reduction of symptoms and ulcer takes less time to heal.

Kajjalikodaya Malahara is mentioned in Bhaishajaratnavali is having properties like Lekhana, Krimigna, Shodhana and Ropana, It acts as Vranashodhaka and Vranaropaka, so it has been selected in the treatment of Parikartika.

Jatyadi Ghrita is having properties like Tridoshahara, Lekhana, Shodhana and *Ropana,*which acts as Vedanahara, Vranashodhaka and Vranaropaka.

Hence the present study is undertaken to evaluate and compare the efficacy of Kajjalikodaya Malahara Pichu and Jatyadi Ghrita Pichu in the management of Parikartika with special reference to Acute Fissure-in-Ano.

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

入选标准

  • •1 Patients diagnosed with parikartika are selected.
  • •2.Patients aged between 18 – 60 years of either gender.

排除标准

  • •1 Patients diagnosed with other co-existing Ano rectal diseases, like hemorrhoids, fistula-in-ano, Ca rectum etc.
  • •2 Patients of chronic fissure -in- ano with sentinel pile.
  • •3 Patients with uncontrolled diabetes and hypertension.
  • •4 Fissure-in-ano due to systemic disorders like ulcerative colitis, Crohns disease etc.
  • •5 Patients suffering from infectious diseases, like RVD, Syphilis, HbsAg etc.

结局指标

主要结局

Reduction in pain,burning sensation,bleeding per rectum and constipation

时间窗: 18 days

次要结局

  • Reduction in the size of ulcer

研究者

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

Dr Pravin Birajadar

BVVS Ayurved Medical College and Hospital

研究点 (1)

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