Treatment of Haemorrhoids through Unani Medicine

Evaluation of the efficacy of Unani Formulation Itrifal Saghir and Abzan (Sitz bath) in Management of Baw ?sir (haemorrhoids) and its effect on biomarkers–An open prospective clinical trial.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/058042

Enrollment

120

Registered

2023-09-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K641- Second degree hemorrhoids

Interventions

Intervention1: Itrifal Saghir : Itrifal Saghir is a semisolid compound formulation consisting of Post Halela Zard (Terminalia chebula Retz), Post Halela Kabuli(Terminalia chebula Retz.), Halela Seyah

Eligibility

Inclusion criteria

Inclusion criteria: Patients of any sex in the age group more than 18 Patients with a diagnosis of First and Second Degree Haemorrhoids presenting with any three of the following symptoms: 1.Jarayan al Dam fi’l Maq’ad (bleeding per rectum): Bright-red, painless bleeding 2.Sayalan al Maq’ad Mukhati (mucoid anal/perianal discharge: mucus discharge 3.Hikka al-Maq’ad (pruritus ani) 4.Khuruj al-Mukhatiya (mucosal prolapse) with Spontaneous Reduction 5.Waja’al Maq’ad (rectal/anal pain): on prolapse

Exclusion criteria

Exclusion criteria: The following patients will be excluded from the study: 1.Pregnant and Lactating Women. 2.Diabetic patients. 3.Third & Fourth Degree Haemorrhoids, anal fissure, anal fistula, IBD, Diabetes Mellitus 4. Known cases of other clinically significant co-morbid conditions (severe hepatitis, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study. 5.History of alcohol and drug abuse. 6.Patient planning to undergo any surgical procedure for hemorrhoids

Design outcomes

Primary

Measure	Time frame
The assessment of the efficacy of the treatment will be carried out based on the main outcome measure of the Colorectal Evaluation of Clinical Therapeutics Scale (CORECTS), (Ebrahimi N 2011) which consists the five chief symptoms of hemorrhoids that are, pain, itching, swelling, bleeding, & discomfort. Each symptom will be rated on a numeric scale from 0 is no symptoms to 10 is worst possible symptoms. In addition, the CORECTS also accounts for quality of life, with an impact on wellbeing (IW) score ranging from 0 (no impact) to 10 (worst possible impact on wellbeing). Overall improvement after treatment ranges from 0 is no improvement at all to 10 is maximal improvement comparable to the healthy state. The efficacy assessment was carried out by comparing the baseline with the post treatment data. Timepoint: 21 days	—

Measure

Time frame

The assessment of the efficacy of the treatment will be carried out based on the main outcome measure of the Colorectal Evaluation of Clinical Therapeutics Scale (CORECTS), (Ebrahimi N 2011) which consists the five chief symptoms of hemorrhoids that are, pain, itching, swelling, bleeding, & discomfort. Each symptom will be rated on a numeric scale from 0 is no symptoms to 10 is worst possible symptoms. In addition, the CORECTS also accounts for quality of life, with an impact on wellbeing (IW) score ranging from 0 (no impact) to 10 (worst possible impact on wellbeing). Overall improvement after treatment ranges from 0 is no improvement at all to 10 is maximal improvement comparable to the healthy state. The efficacy assessment was carried out by comparing the baseline with the post treatment data. Timepoint: 21 days

—

Secondary

Measure	Time frame
Bleeding Per Rectum Mucus Discharge Pruritus Ani Mucosal Prolapse Anal Pain Timepoint: 21 days	—

Countries

India

Contacts

Public ContactMohd Afsahul Kalam

Regional Research Institute of Unani Medicine (RRIUM), Srinagar

afsahnium@gmail.com7051435488

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026