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临床试验/CTRI/2025/03/083525
CTRI/2025/03/083525尚未招募2 期

A Randomized Control Trial to evaluate the efficacy of Nyagrodadi Rectal Suppository in the management of Parikartika with special reference to Acute Fissure In Ano

BVVS Ayurveda 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: 2025年3月27日最近更新:
适应症
相关药物

试验速览

阶段
2 期
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 size, burning sensation,bleeding per rectum and constipation

研究概览

简要总结

Parikartika is one of the common anorectal diseases observed in day-to-day clinical practice. Parikartika is a complication of Basti Karma, Virechana Vyapath, Atisara, Grahani and Arsharoga as mentioned in classics’ It is caused by Sthana Samshraya of vitiated Vata and Pitta Doshas in Gudapradesh. It can be co-related with fissure-in-ano of the contemporary science.

Fissure-in-ano is characterized by severe pain burning sensation during and after defecation, severe constipation, and there is a drop of blood or streak of fresh blood on stool. It occurs equally in both men and women and is common in all age group especially age group of 15-40 years".

Nowadays due to sedentary lifestyle, patients suffering from constipation and rectal diseases are quite high in number. It is most painful condition affecting the anal region. About 30-40% of the population suffers from proctologic pathologies at least once in their lives, in that anal fissure comprises of 10-15%.

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 dilation whereas surgical intervention includes Lord’s dilation, posterior fissurectomy and lateral anal sphincterotomy.

Parikartika is considered as Sadyovrana, Acharya Sushruta has mentioned Varti Prayoga in the context of Shashti Upakrama in the management of Vrana". Contemporary suppositories are slight modification of ancient formulations and medicated solid dose. Therefore, recent advances can be utilized for moulding varti into suppository.

Rectal Suppository offer patients, an option that is minimally invasive and easy to use in relieving rectal complaints. The absorption occurs at the site of administration, therefore rapid absorption with a rapid increase in plasma drug level can be achieved. For fissure, there needs to be a treatment that acts locally and systemically. Suppositories would act locally for wound healing and. systemically for hemostasis, laxative.

There are many drugs in ayurvedic Samhitas which are known to reduce pain by their Vedanasthapaka and Shoolahara properties, to heal wounds by their Vranaropana and Vranashodana properties, to stop bleeding by their Rakthastambhana and Shonitastapana properties, to reduce constipation by Deepana, Pachana and Anuloma properties". Keeping all these considerations rectal suppository is made named as Nygrodadi suppository, which is composed Nyagrodha, Udumbara, Shallaki, Yastimadhu, Rohini and Jambu and having properties like Shoolahara, Shodana, Ropana, Raktasthambana, Daha Prashamama. So, it acts as Vrana Shodhaka and Vrana Ropaka"

Corect suppository is a combination medicine which contains hydrocortisone acetate, lignocaine, zinc oxide, allantoin used to treat pain and bleeding associated with anal fissures and haemorrhoids".

Hence the present study is undertaken to evaluate and compare the efficacy of Nyagrodadi suppository and corect suppository 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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients diagnosed with Parikartika (Acute Fissure-in-Ano) 2.Patients aged between 18-60 years, irrespective of gender.

排除标准

  • •1.patient diagnosed with other co-existing Anorectal diseases like haemorrhoids (3rd and 4th degree) fistula in ano and Ca rectum etc.
  • •2.Patients of chronic fissure in ano with sentinel pile and anal papillae.
  • •3.Patient with uncontrolled diabetes and hypertension.
  • •4.Fissure in Ano due to systemic disorders like ulcerative colitis ,Crohns disease etc 5.Patient suffering from infectious diseases like RVD ,Syphilis ,HbsAg etc.

结局指标

主要结局

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

时间窗: 7 days

次要结局

  • Reduction in the size of the ulcer(7 days)

研究者

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

Dr Shridevi

BVVS Ayurved Medical College and Hospital Bagalkot

研究点 (1)

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