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临床试验/CTRI/2025/07/090045
CTRI/2025/07/090045尚未招募2 期

Therapeutic Evaluation Of Marham-e-Dafe-Shiqaq-al-Maqad In Case of Shiqaq-al-Maqad(Anal Fissure)

State Takmeel ut Tib 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7月21日最近更新:

试验速览

阶段
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
Improvement in

研究概览

简要总结

Title:

Therapeutic Evaluation of Marham-e-Dafe Shiqaq-al-Maqad in Case of Shiqaq-al-Maqad (Anal Fissure)

Researcher:

Dr Saquib Raza PG Scholar Department of Ilmul Jarahat

State Takmeel-ut-Tib College and Hospital Lucknow

Overview:

This clinical research aims to evaluate the effectiveness of a traditional Unani formulation—Marham-e-Dafe Shiqaq-al-Maqad—for treating anal fissures a common and painful anorectal condition

Objectives:

Prevent surgical intervention and associated complications

Assess the healing efficacy of the Unani ointment and laxative combination.

Halt progression of acute fissures into chronic ones.

Methodology:

Design: Open-label single-arm interventional clinical study

Sample Size: 30 patients (18–60 years)

Duration: 6 weeks

Treatment:

Topical: Marham-e-Dafe Shiqaq-al-Maqad (BD)

Oral: Safoof Mulaiyyan (5g at bedtime)

Assessment Tools: Clinical exam Visual Analogue Scale (VAS) for pain rectal examination

Inclusion/Exclusion: Patients with simple anal fissures included other anorectal or systemic conditions excluded

Outcomes:

Measured through symptom relief (pain bleeding constipation healing of fissure and safety parameters (blood tests)

Significance:

The study explores a cost-effective side-effect-free alternative from Unani medicine for managing anal fissures especially chronic ones resistant to conservative modern treatments.

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

入选标准

  • Clinically diagnosed cases of Shiqaq-al-Maqad (Anal Fissure) (anterior & posterior) Patients irrespective of sex religion occupation & economical status Patients of both the sexes in between the age group of 18 to 60 years.

排除标准

  • Anal Fistula External sphincter deffect Haemorrhoids Rectal Prolapse Anal/perianal abscess Anal Fissure secondary to Ulcerative colitis Syphilis, Crohn’s disease Tuberculosis and malignancy of rectum and anal canal Pregnancy Advanced Anal Fissure Venereal diseases Severe anaemia Mentally Retarded Patients.

结局指标

主要结局

Improvement in

时间窗: Clinical assessment will be done at 0,14th, 28th & 42nd days.

Pain during & after defection

时间窗: Clinical assessment will be done at 0,14th, 28th & 42nd days.

Constipation

时间窗: Clinical assessment will be done at 0,14th, 28th & 42nd days.

Per rectal bleeding

时间窗: Clinical assessment will be done at 0,14th, 28th & 42nd days.

次要结局

  • Diagnosed by simple rectal examination(Visual Analogue Scale (VAS))

研究者

发起方
State Takmeel ut Tib College And Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR SAQUIB RAZA

State Takmeel ut Tib College And Hospital

研究点 (1)

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