A Comparative Clinical Study to evaluate the efficacy of Suranawleha and Suranvatak in the management of Shushka Arsha with special reference to Haemorrhoids.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To reduce signs and symptoms of constipation,anal itching in management of Shushka arsha with special reference to Haemorrhoids
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To reduce signs and symptoms of constipation,anal itching in management of Shushka arsha with special reference to Haemorrhoids
时间窗: 21 days
次要结局
- To provide long term relief & reduce recurrence(21 days)