Health Condition 1: K640- First degree hemorrhoids
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of any sex in the age group 18 to 65 years 2. Patients with a diagnosis of First and Second Degree Hemorrhoids presenting with any of the following symptoms: Mucoid Anal/ Perianal Discharge (Sayal ?n al- Maq‘ad Mukh ?ti): mucus discharge Pruritus Ani (Hikka al-Maq‘ad) Mucosal Prolapse (Khuruj al-Mukh ?tiyya) with Spontaneous Reduction Rectal/ Anal Pain (Waja‘ al-Maq‘ad): on prolapse
Exclusion criteria
Exclusion criteria: 1. Third & Fourth Degree Haemorrhoids, anal fissure, anal fistula, IBD, Diabetes Mellitus 2. Bleeding Per Rectum (Jaray ?n al-Dam fi’l Maq‘ad): bright-red, painless bleeding 3. Known cases of clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.) 4. Patients with laboratory values outside the normal limits or those with values considered abnormal. 5. Known hypersensitivity to study drug or any of its ingredients 6. History of alcohol and drug abuse 7. Pregnant and Lactating Women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of the study drug in the treatment of Baw ?sir ?miya (Non-Bleeding Piles) will be assessed on the basis of reduction in the symptoms and signs of the disease. The symptoms will be graded on a Visual Analogue Scale (VAS) of 0 to 100 mm, wherein 0 indicates no symptom and 100 indicates maximum intensity.Timepoint: At baseline, days 7, 14, 28 and 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.Timepoint: At baseline and after 42days | — |
Countries
India
Contacts
Central Council for Research in Unani Medicine (CCRUM)