A randomized controlled clinical study to evaluate the efficacy of yashtimadhu tila kalka ksheera basti in parikartika vis-Ã -vis fissure in ano
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To relieve pain
Study Overview
Brief Summary
Fissure in ano is the commonest among anorectal disorders. Anal fissure is longitudinal split in anoderm of the distal anal canal which extends from anal verge proximally towards, but not beyond dentate line. Similarly, Parikartika is explained in ayurveda as excruciating cutting pain in the anal region. Every individual suffers from proctological symptoms at least once in their lifetime.
Yashtimadhu ghrita Matra Basti is a Shamana Basti and it helps in wound healing. Yashtimadhu Tila Kalka Ksheera Basti on the other hand not only helps in wound healing but also acts as Shodhana Basti due to its Matra, thus preventing or treating Pureeshavaha Sroto Vikaras thereby regulating sphincter tone and preventing constipation. Yahtimadhu Tila Kalka Ksheera Basti is mentioned in Basti Vyapath.
This is a clinical study between study group and control group. Minimum 40 clinically diagnosed patients of Parikartika (fissure in ano) are selected based on inclusion and exclusion criteria. The parameters of signs, symptoms and investigation will be scored on the basis of standard method and will be analyzed statistically. Registered patients will be allotted randomly into two equal groups of minimum 20 patients each A and B.
Twenty subjects of this group will be subjected to Yashtimadhu Tila Kalka Ksheera Basti ;Dose: 450ml once a day ;Duration: 7 days. Twenty subjects of this group will be subjected to Yashtimadhu Ghrita Matra Basti: Dose: 30ml once a day;Duration: 7days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Clinically diagnosed case of fissure in ano are taken for the study.
- •2.Patient of both sexes with age group of 18 to 60years.
- •3.Patients irrespective of religion, Occupation and economic status.
- •4.Acute fissure in ano and chronic fissure with acute onset.
Exclusion Criteria
- •1.Patients having Fissure-in-ano secondary to Ulcerative colitis, Crohn’s disease, tuberculosis and malignancy of rectum and anal canal.
- •2.Patients with infectious diseases like HIV& HBsAg. 3.Patients with fissure associated with Hemorrhoids and Fistula-in- ano.
Outcomes
Primary Outcomes
To relieve pain
Time Frame: 4th day
Secondary Outcomes
- To cure pain, bleeding, constipation(7days)
Investigators
Dr A R Sumanth Acharya
Muniyal Institute of Ayurveda Medical Sciences, Manipal