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Clinical Trials/CTRI/2021/05/033587
CTRI/2021/05/033587CompletedNot Applicable

“A RANDOMIZED COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF TRIPHALA GHRITA GUDA-PICHU WITH TRIPHALA KWATHA AVAGAHA SWEDA IN THE MANAGEMENT OF PARIKARTIKA w.s.r. TO FISSURE-IN-ANOâ€

Shri Dharamshala manjunatheshwara college of ayurveda kuthpadyudupi1 site in 1 country40 target enrollmentStarted: May 20, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
wound is healing & size reduced.No constipation will be there.

Study Overview

Brief Summary

The current study will be â€œA RANDOMIZED COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF TRIPHALA GHRITA GUDA-PICHU WITH TRIPHALA KWATHA AVAGAHA SWEDA IN THE MANAGEMENT OF PARIKARTIKA w.s.r. TO FISSURE-IN-ANOâ€. in this study minimum of 40 diagnosed case of parikartika w.s.r. fissure in ano will be choosen**.**METHOD OF PLACING GUDA-PICHUA gauze piece is dipped in the triphala ghrita and is to be placed in the anus gently for 15 minutes.Explaining and demonstrating the method of Guda – Pichu to the patient on the day of consultation is to be done. The patient will be asked to do the same procedure, once daily for 7 days after the bowel has been passed.Method of Avagaha Sweda  The patient is made to sit in a tub which is filled with luke warm triphala kwatha . The level of the kwatha should beabout 3 to 4 inches (7.6 to 10.2cm).The temperature of the kwatha is maintained by replacing the cold kwatha with warm one frequently.This procedure is to be done for 15 minutes.The patient will be asked to do the same procedure, once daily, for 7 day after the bowel has been passed.

Study Design

Study Type
Interventional
Allocation
Adaptive randomization, such as minimization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with clinical signs and symptoms of Parikartika ( Fissure in Ano ) as explained in Ayurvedic Classics.
  • Subjects fulfilling diagnostic criteria who are willing to give their written informed consent and follow up the protocol of study will be selected.

Exclusion Criteria

  • Patients suffering from systemic diseases like uncontrolled diabetes mellitus, tuberculosis , HIV, hepatitis.
  • Patients with associated anorectal diseases like complicated hemorrhoids , polyp, fistula in ano , crohn’s disease, ulcerative colitis and malignancy.

Outcomes

Primary Outcomes

wound is healing & size reduced.No constipation will be there.

Time Frame: 1week 2weeks and 3weeks

Reduction in pain,Burning sensation.

Time Frame: 1week 2weeks and 3weeks

Secondary Outcomes

  • Improvement of sphincter tone.(7 days)

Investigators

Sponsor
Shri Dharamshala manjunatheshwara college of ayurveda kuthpadyudupi
Sponsor Class
Private medical college

Study Sites (1)

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