CTRI

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CTRI Number

CTRI/2026/02/103889 [Registered on: 16/02/2026] Trial Registered Prospectively

Last Modified On:

16/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda
Surgical/Anesthesia

Study Design

Other

Public Title of Study

Comparison of Hemorrhoidectomy vs. Finger Guided Hemorrhoidal Artery Ligation for Grade III Hemorrhoids

Scientific Title of Study

A Comparative Clinical Study To Evaluate Efficacy Of Hemorrhoidectomy Versus Finger Guided Hemorrhoidal Artery Ligation In The Management Of Grade III Hemorrhoids

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Abhinandan Manhas
Designation	M.S. Scholar
Affiliation	Jammu Institute of Ayurveda and Research
Address	Department of P.G. Studies in Shalya Tantra, Jammu Institute of Ayurveda and Research, Nardni Bajwan, Bantalab Jammu - 181123 Jammu JAMMU & KASHMIR 181123 India
Phone	7006433474
Fax
Email	abhinandansinghmanhas@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Arjun Gupta
Designation	Associate Professor
Affiliation	Jammu Institute of Ayurveda and Research
Address	Department of P.G. Studies in Shalya Tantra, Jammu Institute of Ayurveda and Research, Nardni Bajwan, Bantalab Jammu - 181123 Jammu JAMMU & KASHMIR 181123 India
Phone	9622007600
Fax
Email	dr.arjungupta17@gmail.com

Details of Contact Person
Public Query

Name	Dr Arjun Gupta
Designation	Associate Professor
Affiliation	Jammu Institute of Ayurveda and Research
Address	Department of P.G. Studies in Shalya Tantra, Jammu Institute of Ayurveda and Research, Nardni Bajwan, Bantalab Jammu - 181123 Jammu JAMMU & KASHMIR 181123 India
Phone	9622007600
Fax
Email	dr.arjungupta17@gmail.com

Source of Monetary or Material Support

Jammu Institute of Ayurveda and Research, Nardani, Jammu, Jammu And Kashmir, 181123, INDIA

Primary Sponsor

Name	Jammu Institute of Ayurveda and Research
Address	Jammu Institute of Ayurveda and Research, Nardni Bajwan, Bantalab Jammu - 181123
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Abhinandan Manhas	Jammu Institute of Ayurveda and Research	Shalya Tantra OPD of JIAR hospital of Jammu Institutre Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu, Jammu And Kashmir 181123 Jammu JAMMU & KASHMIR	7006433474 abhinandansinghmanhas@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Jammu Institute Of Ayurveda And Research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K642\|\|Third degree hemorrhoids,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Finger-Guided Hemorrhoidal Artery Ligation with Mucopexy	Non-excisional technique using finger-guided identification of hemorrhoidal arteries. Terminal branches of superior hemorrhoidal artery are ligated above the dentate line, combined with mucopexy for prolapse correction, under anesthesia. For each patient: 3 months (90 days), including follow-up
Intervention	Milligan-Morgan Hemorrhoidectomy	Conventional excisional hemorrhoidectomy using Milligan-Morgan technique under anesthesia. Hemorrhoids are ligated at the base and removed surgically. For each patient: 3 months (90 days), including follow-up

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Patients aged between 18 and 70 years 2. Patients of either sex 3. Patients with primary hemorrhoids 4. Patients clinically diagnosed with Grade III internal hemorrhoids 5. Patients who are medically fit for surgery under spinal anesthesia 6. Patients who are willing and able to provide written, informed consent

ExclusionCriteria

Details

1. Patients with Grade I, II, or IV hemorrhoids
2. Patients with a history of previous surgery for any anal disorder
3. Patients presenting with acute complications such as thrombosed or strangulated hemorrhoids
4. Patients with Significant fecal incontinence
5. Patients with other active anorectal diseases, including chronic anal fissure with severe sphincter spasm,
fistula-in-ano, or perianal abscess
6. Patients with known coagulopathies or on therapeutic anticoagulation that cannot be safely discontinued
7. Pregnant or lactating women
8. Patients with an altered cognitive status who are unable to provide informed consent

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Disease recurrence (reappearance of primary symptoms - prolapse of Grade II or higher or significant bleeding) confirmed on proctoscopy	At 90-day follow-up

Secondary Outcome

Outcome	TimePoints
Post-operative Pain Intensity	24 hours, 48 hours, 7 days, 30 days, 60 days, and 90 days
Post-operative Analgesic Requirement	Up to 90 days
Mean Operative Time	Day 0
Intra-operative Blood Loss	Day 0
Duration of Hospital Stay	Day 0 to 90
Time to Return to Normal Activities	Up to 90 days
Post-operative Complications	24 hours, 48 hours, 7 days, 30 days, 60 days, and 90 days
Severity of Bleeding	7 days, 30 days, 60 days, and 90 days
Severity of Itching and Discharge	7 days, 30 days, 60 days, and 90 days

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

01/05/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is a prospective, randomized, open-label comparative clinical study conducted at Jammu Institute of Ayurveda and Research, Jammu, to evaluate and compare the efficacy, safety, and postoperative outcomes of Milligan–Morgan Hemorrhoidectomy versus Finger-Guided Hemorrhoidal Artery Ligation (FGHAL) with mucopexy in patients suffering from Grade III internal hemorrhoids (Arsha Roga).

A total of 40 patients aged 18–70 years with clinically diagnosed Grade III hemorrhoids will be enrolled and randomly allocated into two groups:

• Group A (n=20): Milligan–Morgan Hemorrhoidectomy

• Group B (n=20): Finger-Guided Hemorrhoidal Artery Ligation with Mucopexy

The study duration is 18 months, with each patient followed for 90 days post-procedure. Primary outcome measure is recurrence at 90 days. Secondary outcomes include postoperative pain (VAS score), intra-operative blood loss, operative time, analgesic requirement, hospital stay, time to return to normal activities, and postoperative complications.

Assessments will be performed at 24 hours, 48 hours, 7 days, 30 days, 60 days, and 90 days. Statistical analysis will be carried out using SPSS software.

The study aims to determine whether FGHAL offers a better postoperative recovery profile with comparable efficacy, or whether conventional hemorrhoidectomy provides superior disease control despite higher morbidity. Institutional Ethical Committee approval has been obtained prior to initiation of the trial.