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Clinical Trials/CTRI/2024/07/071599
CTRI/2024/07/071599Not yet recruitingPhase 2

Evaluation of the efficacy of Ardraka ksharasutra in the management of Arshas.

Dr Krishnaji Sadanand Patil1 site in 1 country60 target enrollmentStarted: August 2, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Effect of treatment will be assessed on the basis of gradation of both subjective and objective parameters before and after treatment.

Study Overview

Brief Summary

THE TRIAL WILL BE STARTED ONLY AFTER THE CTRI APPROVAL. PATIENTS WILL BE UNDER TRIAL IN BOTH THE GROUPS. KSHARASUTRA PREPARATION WILL BE DONE FOR THE GROUPS AND THE EFFICACY OF KSHARASUTRA IN THE MANAGEMENT OF ARSHAS WILL BE ASSESSED UNDER  DEPARTMENTAL SUPERVISION AT THE INSTITUTION.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • The patients having classical symptoms of Arshas will be selected.
  • Patients will be selected between the age group of 18-70 yrs of either gender, irrespective of religion, occupation, Socio-economic status.
  • Patients diagnosed with 2nd, 3rd and 4th degree internal haemorrhoids, Interno-external haemorrhoids, thrombosed haemorrhoids.
  • Controlled systemic illness like Hypertension and Diabetes mellitus.

Exclusion Criteria

  • Patients suffering secondary to inflammatory diseases like Ulcerative colitis, Crohn’s disease.
  • Haemorrhoids associated with Fissure in Ano, Fistula in Ano, Anal stricture, Perianal abscess, Malignancy and Polyps.
  • Patients suffering from HIV, Tuberculosis and CA of rectum and Hepatitis B Pregnant women.

Outcomes

Primary Outcomes

Effect of treatment will be assessed on the basis of gradation of both subjective and objective parameters before and after treatment.

Time Frame: 45th, 60th day

Ruja (Post-operative Pain)

Time Frame: 45th, 60th day

Srava (Discharge per rectum)

Time Frame: 45th, 60th day

Rakta Srava (Bleeding P/R)

Time Frame: 45th, 60th day

Secondary Outcomes

  • The Below Criteria will be Checked.(1.Tenderness)

Investigators

Sponsor
Dr Krishnaji Sadanand Patil
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

DR Krishnaji Sadanand Patil

Alvas Ayurveda Medical College and Hospital, Moodubidre, Vidyagiri, Dakshina Kannada, Karnataka

Study Sites (1)

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