HemorrhoidNCT07199673
Comparison of Outcome of Injection Sclerotherapy Versus Rubber Band Ligation for Second Degree Hemorrhoids
A study testing Injection Sclerotherapy and Rubber Band Ligation in people with Hemorrhoid, run by Gulab Devi Hospital at 1 site in Pakistan.
Trial summary
Objective of this study is to compare the outcome of Injection Sclerotherapy versus Rubber Band Ligation for second degree hemorrhoids in terms of bleeding and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoid
- What is being tested?
- Injection Sclerotherapy and Rubber Band Ligation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Jul 2025to 6 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 75 who have been diagnosed with second-degree hemorrhoids
Who cannot join
- Patients with thrombosed hemorrhoids, and those with serious comorbid conditions such as heart, kidney, or liver diseases, coagulation disorders, or severe anemia.
- Individuals who have received treatment for hemorrhoids in the past six months.
- Pregnant women.
- Patients unable to commit to necessary follow-up appointments.
- Patients with a history or current presence of colorectal cancer or anal malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Injection Sclerotherapy and Rubber Band Ligation in Second-Degree Hemorrhoids: A Randomized Controlled Trial
Objective of this study is to compare the outcome of Injection Sclerotherapy versus Rubber Band Ligation for second degree hemorrhoids in terms of bleeding and efficacy.
Read the detailed description
There is a difference in the outcome of Injection Sclerotherapy versus Rubber Band Ligation for second degree hemorrhoids in terms of bleeding and efficacy.
- Conditions
- Hemorrhoid
- Being tested
- Injection Sclerotherapy, Rubber Band Ligation
- Keywords
- Injection Sclerotherapy, Rubber Band Ligation, Second Degree Hemorrhoids
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection SclerotherapyDrug
identifying the hemorrhoidal pedicle, 3-5 ml of 5% phenol in almond oil is injected into the submucosal plane of the hemorrhoid pedicle
Rubber Band LigationDevice
knee-elbow position is used. After identifying the hemorrhoids with a proctoscope, a rubber band is applied at the base of each hemorrhoid using Barron's Gun and Elise's tissue forceps.
| Study group | Role | What they receive |
|---|---|---|
| Group IST | Other | 5% phenol in almond oil Receives: Drug: Injection Sclerotherapy |
| Group RBL | Other | rubber band is applied at the base of each hemorrhoid using Barron's Gun and Elise's tissue forceps. Receives: Device: Rubber Band Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early per rectal Bleeding
within 24 hours post-procedure
Measured: 24 hours
Secondary outcomes (1)
Delayed Bleeding Per rectal
24 hours to 14th post-operative day
Measured: 24 hours to 14th post operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start7 Jul 2025
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulab Devi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mudassar Malik, Gulab Devi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199673
- Sponsor's protocol ID
- AAMC/IRB/EA252025
- Status last verified
- Jun 2026
- First submitted
- 19 Sep 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: i am collecting my data for study. I did not completed my data. so i am unable to share
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Injection Sclerotherapy and Rubber Band Ligation in Second-Degree Hemorrhoids: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07199673
- Acronym / sponsor ID
- AAMC/IRB/EA252025
- Conditions
- Hemorrhoid
- Keywords
- Injection Sclerotherapy, Rubber Band Ligation, Second Degree Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Gulab Devi HospitalUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective of this study is to compare the outcome of Injection Sclerotherapy versus Rubber Band Ligation for second degree hemorrhoids in terms of bleeding and efficacy.
Detailed description
There is a difference in the outcome of Injection Sclerotherapy versus Rubber Band Ligation for second degree hemorrhoids in terms of bleeding and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group IST | Other | Drug: Injection Sclerotherapy5% phenol in almond oil |
| Group RBL | Other | Device: Rubber Band Ligationrubber band is applied at the base of each hemorrhoid using Barron's Gun and Elise's tissue forceps. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged between 18 and 75 who have been diagnosed with second-degree hemorrhoids
Key exclusion criteria (5 listed)
- Patients with thrombosed hemorrhoids, and those with serious comorbid conditions such as heart, kidney, or liver diseases, coagulation disorders, or severe anemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection Sclerotherapyidentifying the hemorrhoidal pedicle, 3-5 ml of 5% phenol in almond oil is injected into the submucosal plane of the hemorrhoid pedicle | Drug | Group IST |
| Rubber Band Ligationknee-elbow position is used. After identifying the hemorrhoids with a proctoscope, a rubber band is applied at the base of each hemorrhoid using Barron's Gun and Elise's tissue forceps. | Device | Group RBL |
Primary outcome
Early per rectal Bleeding
Time frame: 24 hours
within 24 hours post-procedure
1 secondary outcome
Delayed Bleeding Per rectal
Time frame: 24 hours to 14th post operative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No. i am collecting my data for study. I did not completed my data. so i am unable to share
Related trials for Hemorrhoid
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection Sclerotherapy and Rubber Band Ligation in people with Hemorrhoid, run by Gulab Devi Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early per rectal Bleeding (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.