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
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 a...
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JMIR Publications
2025-02-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e63063 |
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| author | Pratap Shankar KM Indu Puthan Purayil Palengara Binitha Amit Kumar Rai Sophia Jameela Azeem Ahmad Chandra Sekhara Rao Bhogavalli Narayanam Srikanth Rabinarayan Acharya |
| author_facet | Pratap Shankar KM Indu Puthan Purayil Palengara Binitha Amit Kumar Rai Sophia Jameela Azeem Ahmad Chandra Sekhara Rao Bhogavalli Narayanam Srikanth Rabinarayan Acharya |
| author_sort | Pratap Shankar KM |
| collection | DOAJ |
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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 |
| format | Article |
| id | doaj-art-3abc81b262494049b75c37737dedb395 |
| institution | Kabale University |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | JMIR Publications |
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| series | JMIR Research Protocols |
| spelling | doaj-art-3abc81b262494049b75c37737dedb3952025-02-03T17:00:36ZengJMIR PublicationsJMIR Research Protocols1929-07482025-02-0114e6306310.2196/63063Efficacy and Safety of Murivenna Anal Infiltration Compared to Diltiazem Topical Application in Chronic Anal Fissure: Protocol for a Prospective, Randomized, Open-Label Clinical TrialPratap Shankar KMhttps://orcid.org/0000-0002-6612-0297Indu Puthan Purayilhttps://orcid.org/0000-0003-1400-2288Palengara Binithahttps://orcid.org/0000-0002-9406-4886Amit Kumar Raihttps://orcid.org/0000-0002-2798-5933Sophia Jameelahttps://orcid.org/0000-0001-6685-3610Azeem Ahmadhttps://orcid.org/0000-0003-1866-0050Chandra Sekhara Rao Bhogavallihttps://orcid.org/0000-0001-5408-3225Narayanam Srikanthhttps://orcid.org/0000-0002-3976-4978Rabinarayan Acharyahttps://orcid.org/0000-0003-4413-1937 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)DERR1-10.2196/63063https://www.researchprotocols.org/2025/1/e63063 |
| spellingShingle | Pratap Shankar KM Indu Puthan Purayil Palengara Binitha Amit Kumar Rai Sophia Jameela Azeem Ahmad Chandra Sekhara Rao Bhogavalli Narayanam Srikanth Rabinarayan Acharya 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 JMIR Research Protocols |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://www.researchprotocols.org/2025/1/e63063 |
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