Evidence map›Paper›PMID 39899833›Full record

ArticleJMIR research protocols2025

Efficacy and Safety of Murivenna Anal Infiltration Compared to Diltiazem Topical Application in Chronic Anal Fissure: Protocol for a Prospective, Randomized, Open-Label Clinical Trial.

Pratap Shankar Km, Indu Puthan Purayil, Palengara Binitha, Amit Kumar Rai, Sophia Jameela, Azeem Ahmad, Chandra Sekhara Rao Bhogavalli, Narayanam Srikanth, Rabinarayan Acharya

Abstract readClinical Trial Protocol
In one paragraph

Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Pratap Shankar KmNational Ayurveda Research Institute for Panchakarma, Central Council for Research in Ayurvedic Sciences, New Delhi, India.ORCID 0000-0002-6612-0297
Indu Puthan PurayilNational Ayurveda Research Institute for Panchakarma, Central Council for Research in Ayurvedic Sciences, New Delhi, India.ORCID 0000-0003-1400-2288
Palengara BinithaNational Ayurveda Research Institute for Panchakarma, Central Council for Research in Ayurvedic Sciences, New Delhi, India.ORCID 0000-0002-9406-4886
Amit Kumar RaiAyurvedic and Unani Tibbia College, New Delhi, India.ORCID 0000-0002-2798-5933
Sophia JameelaCentral Council for Research in Ayurvedic Sciences, New Delhi, India.ORCID 0000-0001-6685-3610
Azeem AhmadCentral Council for Research in Ayurvedic Sciences, New Delhi, India.ORCID 0000-0003-1866-0050
Chandra Sekhara Rao BhogavalliCentral Council for Research in Ayurvedic Sciences, New Delhi, India.ORCID 0000-0001-5408-3225
Narayanam SrikanthCentral Council for Research in Ayurvedic Sciences, New Delhi, India.ORCID 0000-0002-3976-4978
Rabinarayan AcharyaCentral Council for Research in Ayurvedic Sciences, New Delhi, India.ORCID 0000-0003-4413-1937

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnal fissure is a common proctologic condition that causes significant pain and anguish to patients, significantly impacting their quality of life and well-being. There are various treatment options for anal fissure, ranging from pharmacological agents that reduce anal sphincter tone to surgical interventions for cases resistant to medical management. Ayurvedic treatments have shown potential for the therapeutic management of anal fissure.

objectiveThis clinical study aims to analyze the efficacy and safety of murivenna anal infiltration compared to diltiazem topical application in chronic anal fissure.

methodsThis is an open-labeled, randomized, controlled parallel group clinical trial with a sample size of 66 participants to be randomized and allocated in a 1:1 ratio to 2 groups. The intervention group will be treated with murivenna anal infiltration, and the control group will be treated with topical application of diltiazem for a period of 4 weeks. The primary outcome will be the proportion of participants demonstrating complete healing after 4 weeks of treatment. The secondary outcomes will be the proportion of participants demonstrating complete healing after 7 days and 14 days of treatment, change in pain at or after defecation, cessation of bleeding, and any recurrence during the study period. Any adverse events will also be recorded during the trial period.

resultsThe project was funded in July 2023, and the study period is 24 months. Participant recruitment started in December 2023. As of August 2024, we have enrolled 50 participants. The data analysis will be complete by June 2025, and the results are expected to be published by August 2025.

conclusionsHigh recurrence rates, adverse effects, incomplete healing, and the negative impact on patients' daily activities and quality of life underscore the need for alternative therapeutic options. Ayurveda offers potential for more sustainable relief with fewer adverse effects. Murivenna oil is a time-tested medicated oil effectively used by Ayurvedic physicians for various ulcers of traumatic and pathological origin. This study will provide scientific evidence on the efficacy and safety of murivenna anal infiltration; further, it can be incorporated into the cost-effective management of chronic anal fissure.

trial registrationClinical Trials Registry India CTRI/2023/09/057330; https://tinyurl.com/y4ut9e8p. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63063.

Indexed as

DiltiazemFissure in AnoAdministration, TopicalAdultChronic DiseaseFemaleHumansMaleMedicine, AyurvedicMiddle AgedProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeDiltiazemanal infiltrationappAyurvedacessation of bleedingchronicchronic anal fissuredefecationdiltiazemefficacymurivennamurivenna anal infiltrationpainproctologicproctologic conditionquality of liferandomized clinical trialstudy protocolsurgical interventiontreatmentwell-being

Identifiers

PMID39899833
PMCPMC11833261

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.