Comparative Clinical Evaluation of Deepana-Pachana with Basti Karma and Kutaj Parpati in Vataj Grahani
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment will be done on the basis of subjective parameters:
研究概览
简要总结
This is a randomized, open-label, parallel-group clinical trial which aims to evaluate the efficacy of Deepana-Pachana alongwith Basti Karma and Kutaj Parpati in the management of Vataj Grahani, one of the commonest disorder of Annavaha Srotas as described in classical Ayurvedic texts, symptoms of which closely resembles to that of Irritable Bowel Syndrome (IBS). The study will be conducted at the Uttarakhand Ayurved University, Gurukul Campus Haridwar. A total of 30 patients diagnosed with Vataj Grahani will be selected from the OPD and IPD of the Department of Panchakarma and participants will be divided randomly into two groups of 15-15 patients in each group. Group A will receive Deepana-Pachana with Chitrakadi Vati and Kala Basti with Shampakadi Asthapana and Bilwa Taila Anuvasana, while Group B will be given Kutaj Parpati. The intervention is based on classical Ayurvedic references recommending Basti Chikitsa and Parpati Kalpana for Grahani Roga. Total duration of treatment will be of 21 days for both the groups and follow-up will be after 15 days of completion of treatment. The observation of the patients will be carried out before, during and after completion of treatment. The obtained results will be discussed on the basis of Ayurvedic concepts and modern scientific parameters. The whole research work will be summarized, and the results obtained on the basis of subjective parameters will be analysed statistically and conclusion will be derived.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 18-60 years of age group.
- •Patients having classical symptoms of Vataj Grahani as mentioned in Brihatatrayi and other Samhitas such as Annam Pachyate Dukham, Shuktapaka, Aadhmanam, Mana Sadnam, Aasyavairasya, Udarshoola, Dravashushka Tanu Apakwa Phenyukta Malapravrutti.
- •Patients who are fit for Basti Karma.
- •Diagnosed and treated cases of IBS.
排除标准
- •Patients suffering from any systemic disorders like uncontrolled diabetes, hypertension, cardiac disease, thyroid disorders, renal dysfunction, which can interfere with the course of disease and treatment.
- •Life threatening disease like abdominal Koch’s, CA colon and partial abdominal obstruction will be excluded.
- •Patient with past history of surgery of GI tract.
- •K/C/O – Amoebiasis, tropical sprue, ulcerative colitis, Crohn’s disease, celiac disease, gastric ulcers, intestinal obstruction.
结局指标
主要结局
Assessment will be done on the basis of subjective parameters:
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Annam Pachyate Dukham (Difficulty in digestion)
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Shuktapaka(Dyspepsia)
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Aadhmanam (Abdominal distension)
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Mana Sadnam(Psychological disturbances)
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Aasyavairasya (Altered taste of mouth)
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Udarshoola (Abdominal pain)
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Drava Shushka Tanu Apakwa Phenyukta Malapravrutti
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Alteration of bowel habits
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Punah Punah Srijeta Varcha (Feeling of incomplete evacuation after defecation)
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
• Other symptoms.
时间窗: Assessment will be done at baseline, on 21th day and 15 days after completion of treatment
次要结局
- To assess whether there are any additional significant findings(At baseline, 21th day & 15 days after completion of treatment.)
研究者
Roshni Ramola
Uttarakhand Ayurved University, Gurukul campus, Haridwar