A Comparative Clinical Study to evaluate the efficacy of Suranawleha and Suranvatak in the management of Shushka Arsha with special reference to Haemorrhoids.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To reduce signs and symptoms of constipation,anal itching in management of Shushka arsha with special reference to Haemorrhoids
Study Overview
Brief Summary
Study Title:
A Comparative Clinical Study to Evaluate the Efficacy of Suranawleha and Suranvatak in the Management of Shushka Arsha with Special Reference to Haemorrhoids
Background:
Shushka Arsha, correlating with dry-type haemorrhoids, is a common anorectal disease which is well known for its chronicity, recurrences &
frequent acute exacerbations .Ayurvedic literature offers various herbal formulations for its management, among which Suranawleha and Suranvatak can be used.
Objective:
1.Primary Objective
To study the effect of Suranawleha as compared to Suranvatak in management of Shushka Arsha wsr to Haemorrhoids .
2.Secondary Objective
-
To study in detail Arsha as per Ayurvedic literature.
-
To study in detail Haemorrhoids as per Modern science.
-
To study in detail about the drug Suranawleha.
Design: Comparative clinical trial
Participants:
Patients diagnosed with Shushka Arsha (1st & 2 nd degree piles) of ahe group 16-80 years meeting the inclusion and exclusion criteria will be selected from OPD and IPD of Shalyatantra department of Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital, Nashik.
Intervention Groups:
Group A: Treated with Suranawleha
Group B: Treated with Suranvatak
Duration:
Treatment duration:21 days
Follow up on 7 ,14 & 21 st day
Assessment Criteria:
Symptomatic relief (pain, constipation), reduction in pile mass, and overall quality of life.
Expected Outcome:
The study aims to determine which formulation provides better symptomatic relief and therapeutic outcomes, thereby guiding effective Ayurvedic management protocols for haemorrhoids.
Overall Assessment of Therapy:
Observations and results will be formulated in accordance with the assessment
criteria.
12.Conclusion:
The conclusion will be derived exclusively from the statistical analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients having symptoms of Arsha (1st and 2nd degree piles) 2) Patients of age groups 18-60 years irrespective of gender,socioeconomic status .
- •Patients who are willing to participate in the study and ready to give informed written consent.
Exclusion Criteria
- •Thrombosed prolapsed piles, third, and 4th degree piles .
- •Patient suffering from anorectal pathology other than Arsha.
- •Patient below age group under 18 years and above 70 years.
- •Patients suffering from any serious systemic diseases like hypertension, diabetes mellitus , malignancy, Hepatitis B, HIV, HCV, Tuberculosis 5) Bleeding per rectum.
Outcomes
Primary Outcomes
To reduce signs and symptoms of constipation,anal itching in management of Shushka arsha with special reference to Haemorrhoids
Time Frame: 21 days
Secondary Outcomes
- To provide long term relief & reduce recurrence(21 days)