Health Condition 1: K641- Second degree hemorrhoids
Conditions
Interventions
Intervention1: Durvadi Gudavarti: 1 Gudavarti 12 hourly through Rectal route for 2 weeks.
Control Intervention1: Hydrocortisone based Suppository: 1 Suppository 12 hourly through rectal route for 2 we
Sponsors
Mahatma Gandhi Ayurveda College Hospital Research center Salod Wardha Maharastra
Dr Reena Jaiswal
Dr Suhas Jajoo
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed case of Internal Haemorrhoids of grade 2 (Goligher classification) patients (characterized by bleeding PR, anal pain, pile mass/lump of variable size and appearance possibly red-violet/blue color, anal pruritus, mucous discharge and constipation) Patients having hemoglobin more than or equal to 10 gm% & who will give their written, informed consent to participate will be included for the study
Exclusion criteria
Exclusion criteria: Patient below the age of 20 and above age of 60. Patients having hemoglobin less than 10 gm%. Grade 1, 3 and 4 Haemorrhoids (Goligher classification), external haemorrhoids, external thrombosed haemorrhoids. Haemorrhoids associated with acute Fissure-in-Ano, Fistula in ano, Ulcerative colitis, Crohn’s disease, Malignancy, Intestinal Polyps, Diverticulitis. Patients of TB, Diabetes mellitus and uncontrolled hypertension, portal hypertension, septic or severe hemorrhagic complications, bleeding disorders, acute diarrhea in last 12 hrs, allergy to corticosteroids or any other component of the medicament; on corticosteroids therapy, on anticoagulant medications, on other antihemorrhoidal drugs or planning to undergo any surgical procedure for hemorrhoids. Pregnant & nursing females. HIV and HbsAg positive patients will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with complete clinical response (symptomatic relief) & reduction of more than 50 % of the initial size of pile mass/lump. It will be assessed- Qualitatively as Yes/No, Frequency will be measured quantitatively as as Never/2days apart/Every or Alternate day, Severity of Anal pain will be assessed using linear visual analogue scale (VAS)range 0-10 (0- no pain and 10- worst pain), Severity of PR Bleeding will be assessed subjectively as No, mild, moderate & Severe.Timepoint: Clinical evaluation will be done at Baseline and 3rd, 5th, 10th, 15th day after treatment onset. Main end point will be Proportion of patients with complete clinical response on 10th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to response & need for oral/parenteral medication for pain, bleeding and constipation. Side effects (type, duration, severity & outcome). Severity of side effects will be classified into three levels: Mild, moderate & severe. Relapse of symptoms after end of intervention.Timepoint: At Baseline and 3rd, 5th, 10th, 15th day after treatment onset. 1st & 2nd week after end of intervention. | — |
Countries
India
Contacts
Public ContactDr Nitin Nilratan Biswas
Jawaharlal Nehru medical college
Outcome results
None listed