A study comparing a hemp-herbal topical ointment with topical nifedipine-lidocaine in patients with chronic anal fissure

ISRCTN	ISRCTN65106771
DOI	https://doi.org/10.1186/ISRCTN65106771
Sponsor	Sheba Medical Center
Funder	Investigator initiated and funded

Submission date: 16/04/2026
Registration date: 23/07/2026
Last edited: 23/07/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Edward Ram
Scientific, Principal investigator, Public

Derech Hayam 3 Apartment 50 Acre
Akko
2451619
Israel

ORCID ID	0000-0002-1855-2415
Phone	+972 0525260680
Email	Edward.ram@sheba.health.gov.il

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Participant information sheet	49379_PIS_V1.0.pdf
Scientific title	Efficacy and safety of a hemp-herbal topical ointment versus nifedipine-lidocaine for the treatment of chronic anal fissure: a double-blind randomized controlled trial
Study objectives	To evaluate the efficacy and safety of a hemp-herbal topical ointment compared with topical nifedipine-lidocaine in the treatment of chronic anal fissure, with respect to symptom relief, healing rates, and adverse events.
Ethics approval(s)	Approved 01/12/2022, Institutional Helsinki Committee, Sheba Medical Center (Emek Ha hela, Ramat Gan, 526501, Israel; +972-03-5308916, 972-052-3491626; Helsinki@sheba.health.gov.il), ref: SMC0128-23
Health condition(s) or problem(s) studied	Chronic anal fissure
Intervention	Participants are allocated in a 1:1 ratio using a pharmacy-generated blocked randomisation sequence with blocks of 10 (five allocations to each treatment within every block). The dispensing pharmacy prepares identical coded study tubes according to the randomisation schedule. Participants, investigators, treating clinicians and outcome assessors remain blinded throughout the study. The pharmacy retains the allocation code and emergency unblinding is permitted only when clinically required. Participants were randomly assigned to receive either a hemp-herbal topical ointment or a topical nifedipine (0.3%) plus lidocaine (2%) ointment. Both treatments were applied locally to the anal canal twice daily for a period of 8 weeks. Study medications were prepared in identical containers to maintain blinding. Patients were instructed on a standardized application technique and were followed at predefined intervals for clinical assessment.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Proctofiz MD Ointment, topical nifedipine-lidocaine
Primary outcome measure(s)	Complete fissure healing measured using data on clinical healing, defined as complete epithelialization of the fissure on anorectal examination, without associated pain during defecation at 6 weeks after treatment initiation Pain reduction measured using a Visual Analog Scale (VAS) score at baseline and 6 weeks
Key secondary outcome measure(s)
Completion date	15/11/2025

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	60
Total final enrolment	50
Key inclusion criteria	1. Adults aged ≥18 years with clinically confirmed chronic anal fissure 2. Chronic anal fissure defined as a symptomatic fissure persisting for ≥6 weeks, with typical features on anorectal examination (e.g., sentinel tag, indurated edges, or exposed internal sphincter fibers) 3. Presence of fissure-related pain during or after defecation 4. Ability to provide informed consent 5. A threshold of 3 weeks was used to reflect institutional clinical practice and to include patients with persistent fissures refractory to conservative therapy
Key exclusion criteria	1. Acute anal fissure (<3 weeks duration) 2. Anal fissure associated with inflammatory bowel disease (e.g., Crohn’s disease) 3. Previous anorectal surgery affecting the anal canal 4. Use of topical treatments for anal fissure within 2 weeks prior to enrollment 5. Known hypersensitivity to nifedipine, lidocaine, or components of the study ointment 6. Pregnancy or breastfeeding 7. Severe comorbid conditions that could interfere with study participation or outcome assessment
Date of first enrolment	01/02/2023
Date of final enrolment	22/09/2025

Locations

Countries of recruitment

Israel

Study participating centre

Sheba Medical Center

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Israel

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 1		23/07/2026	No	Yes
Participant information sheet	Patient instructions for ointment application version 1.0		23/07/2026	No	Yes
Protocol file	version 1.0	22/07/2026	23/07/2026	No	No

Additional files

49379_Protocol_v1.0_22July2026.pdf: Protocol file
49379_PIS_V1.0.pdf: Patient instructions for ointment application
49379_PIS and InformedConsent English_v1.pdf: Participant information sheet

Editorial Notes

23/07/2026: Study’s existence confirmed by the Institutional Helsinki Committee at Sheba Medical Center, Israel.