Evaluation of comparative Efficacy of Pileave Ointment versus Pippalyadi Taila in the Management of Grade II Hemorrhoids- A RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction of symptoms of Haemorrhoids:
研究概览
简要总结
•Arsha (Haemorrhoids) are swollen blood vessels of the rectum. 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.
•Ayurveda the ancient science of life, has described it as anorectal disorders in very detailed manner.
•“arivat pranan shrunati hinati itiarshahaâ€
•Zandu Pileave Ointment (ZPO) is a well-known Ayurvedic product being marketed in India to overcome the symptoms associated with dry and bleeding piles.
•The major ingredients are Jatyadi Taila, Nimba taila, Apamarga, Khshara, Yashadbhasma, Tankana Bhasma, amala along with other Ayurvedic ingredients, which are well known to have analgesic, anti-inflammatory, wound healing and antimicrobial properties.
Need of study
To validate the clinical efficacy of ZanduPileave Ointment on the basis of scientific parameters in the patients suffering from Arsha.
To evaluate the safety of Zandu PileaveOintment in the patients suffering from Arsha.
To compare the efficacy of Pileave ointment with the standard of care•
To evaluate the safety of Zandu PileaveOintment in the patients suffering from Arsha.
To compare the efficacy of Pileave ointment with the standard of care
Hypothesis
The drug for proposed study (Zandu PileaveOintment) will be more effective in the management of Arsha (Piles) as compared to Pippalyadi tail.
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
- 15.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from below mentioned minimum three symptoms of piles:
- •Tenderness
- •Bleeding (Hb more than 10gm)
- •Perianal Pain
- •Itching/ irritation.
排除标准
- •Patients suffering from 3rd degree heamorrhoids
- •Patients who develop secondary complication of Colitis, intestinal obstruction etc
- •Any other serious illness e.g. Hepatic or renal failure/Severe Anaemia
- •Known hypersensitivity or allergy to one or more of the herbal ingredients
- •Other debilitating neurological or psychiatric disorders
- •Any condition likely to hinder the compliance with the protocol.
- •Severe infective / other organic illness.
- •Any concomitant serious disorder of organs.
- •Any other drug treatment being received simultaneously on long-term basis.
结局指标
主要结局
Reduction of symptoms of Haemorrhoids:
时间窗: Patients will be assessed 5 times – | Baseline | 7th day | 15th day | 21st day | 30th day (with medication) | 45th day (without medication for follow up) | Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .
1. Swelling
时间窗: Patients will be assessed 5 times – | Baseline | 7th day | 15th day | 21st day | 30th day (with medication) | 45th day (without medication for follow up) | Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .
2. Tenderness
时间窗: Patients will be assessed 5 times – | Baseline | 7th day | 15th day | 21st day | 30th day (with medication) | 45th day (without medication for follow up) | Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .
3. Bleeding (Hb more than 10gm)
时间窗: Patients will be assessed 5 times – | Baseline | 7th day | 15th day | 21st day | 30th day (with medication) | 45th day (without medication for follow up) | Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .
4. Perianal Pain
时间窗: Patients will be assessed 5 times – | Baseline | 7th day | 15th day | 21st day | 30th day (with medication) | 45th day (without medication for follow up) | Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .
5. Burning
时间窗: Patients will be assessed 5 times – | Baseline | 7th day | 15th day | 21st day | 30th day (with medication) | 45th day (without medication for follow up) | Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .
6. Itching/ irritation
时间窗: Patients will be assessed 5 times – | Baseline | 7th day | 15th day | 21st day | 30th day (with medication) | 45th day (without medication for follow up) | Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .
assessment of Hemorrhoidal Disease Symptom Score
时间窗: Patients will be assessed 5 times – | Baseline | 7th day | 15th day | 21st day | 30th day (with medication) | 45th day (without medication for follow up) | Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .
Assessment of Anorectal Symptom Severity and Quality of Life Questionnaire (ARSSQoL)
时间窗: Patients will be assessed 5 times – | Baseline | 7th day | 15th day | 21st day | 30th day (with medication) | 45th day (without medication for follow up) | Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .
次要结局
- Assessment of Anorectal Symptom Severity & Quality of Life Questionnaire ARSSQoL
研究者
Dr Shijo YJ
Shri Dhanwantry Ayurvedic college and Hospital chandigarh