Evaluation of Clinical efficacy of Zandu Abhayarishta in the Management of Arsha (Hemorrhoids) with/without Associated Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in Haemorrhoidal Symptoms: Evaluate the decrease in severity of symptoms such as pain, bleeding, prolapse, and itching as assessed using a validated grading or symptom severity scale over the study period.
研究概览
简要总结
· Arsha are swollen blood vessels of the Anus &lower rectum.1 Anyone at any age can be affected by haemorrhoids. It is very common, with about 50% of people experiencing them at some time in their life. However, it is mostly observed in elderly people and during pregnancy. Ayurveda the ancient science of life, has described it as anorectal disorders in very detailed manner.2**“arivat pranan shrunati hinasti iti arshaha”.**
· Zandu Abhayarishta is a well-known Classical Ayurvedic product from Ayurvedic text “Bharat Bhaishajya Ratnakar”, being marketed in India from more than five decades for the management of the symptoms associated with piles, indigestion & constipation. Zandu Abhayarishta contains Haritaki, Vidanga, Madhuka, Draksha, Dhanyaka,Sunthi, Indravaruni, Trivrit along with other Ayurvedic ingredients which are well known to have analgesic, anti-inflammatory, wound healing and antimicrobial digestive, laxative properties.
Keeping all these facts it is decided to study on “Evaluation of Clinical efficacy of Zandu Abhayarishta in the Management of Arsha (Hemorrhoids) with/without Associated Symptoms.”
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from following minimum 3 symptoms from category A and B of symptoms associated with Arsha will be selected for this study.
- •Category A:
- •Swelling (Sotha)
- •Bleeding /Fissure (Raktashrava/ Parikartika)
- •Perianal Pain (Shula)
- •Burning (Daha)
- •Itching/ irritation (kandu) Category B:
- •Loss of appetite (Kshudhanash)
- •Distended abdomen (Anaha)
- •Flatulence (Adhmana)
- •Acidity (Amlodgar)
- •Kosthabadhata (Constipation).
排除标准
- •1.Patients suffering from 3rd /4th degree piles 2.Patients who develop secondary complication of Colitis, intestinal obstruction etc.
- •3.Any other serious illness e.g., Hepatic/ renal failure/severe anemia.
- •4.Known hypersensitivity or allergy to one or more of the herbal ingredients 5.Other debilitating neurological or psychiatric disorders.
结局指标
主要结局
Reduction in Haemorrhoidal Symptoms: Evaluate the decrease in severity of symptoms such as pain, bleeding, prolapse, and itching as assessed using a validated grading or symptom severity scale over the study period.
时间窗: 45days
次要结局
- Improvement in Quality of Life (QoL): Assess changes in patient-reported QoL using a hemorrhoid-specific QoL questionnaire.(Reduction in Recurrence Rate: Measure the recurrence of hemorrhoidal symptoms within the follow-up period.)
研究者
DRSANJAY SRIVASTAVA
DR.S.R. RAJASTHAN AYURVED UNIVERSITY JODHPUR