A study on impact of shodhana on Phyto-pharmacological properties and biological actions of Bhanga (Cannabis sativa Linn)leaf
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary expected outcome will be reduction in pain and improvement in quality of life and overall associated symptoms in cancer patients
研究概览
简要总结
The drug Bhanga(Cannabis sativa L) has been well reported in the management of post-chemotherapy, post radiation therapy induced side effects and also on cancer symptoms like anorexia, indigestion, depression ,anxiety etc.Being poisonous it has been limited from clinical practice due to its ill effects thus classics advise its shodhana. Classics has mentioned various methods of Bhanga shodhana (purification) as follows: 1)The leaves of Cannabis are tied in a cloth and washed in water which gives a greenish appearance to the water. This process has to continue until the greenish colour stops oozing from the leaves. Afterwards leaves are shade dried.2) The dry leaves washed in water and subjected to drying under sun and later on roasted with cow ghee.
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Fomentation(Swedan) of leaves in cow milk for approx. 3hours then washed with water and roasted in ghee.
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Fomentation in the decoction of Acacia Arabica Willd (Mimosaceae) bark (Babbul twak) for Ghatikardha(12min) with moderate heat and then subjected to drying under sun. Further triturated with cow milk and again dried.
· A pilot study will be done to assess the efficacy of shodhana of Bhanga in improving quality of life in cancer patient’s w.s.r to pain management.Total 40 patients will be studied in one group 20 patients will received morphine as a standards analgesic drug upto 500mg TDS dose and other group 20 patients will receive shodhit (processed)Bhanga churna capsule form in appropriate dose (drawn from animal study) for 30 days followed by follow up of one week to observe withdrawal changes if any.Washout period for morphine will be kept as seven days but in severe pain cases it will be reduced upto 3 days. Chief complaints will be assessed by 1) Wong baker faces scale for pain 2) Neuropathy pain scale 3) Criteria of Assessment for anxiety and depression (Hospital and Anxiety Depression Scale(HADS) Generic) Associated complaint swill be assessed by(if applicable) 1)Criteria for assessment for Quality of life in cancer patients (FACT G Scale) 2)(Profile of Mood States (POMS) Cancer specific )
- NCI–CTC grade for assessment of Nausea and Vomiting 4) National Cancer Institute Common Toxicity Criteria ) for Diarrhoea assessment 5)Criteria for assessment of Constipation (CAS) 6) Criteria for assessment of weight loss 7) Criteria for assessment for dryness of skin. 8) Criteria for assessment of hair loss
Adverse reactions any will be noted too.
The duration of treatment for each patient will be for 1 month and follow up one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Institutionally diagnosed patients of any type of cancer with pain and ECOG score upto
- •Patients willing to participate in trials.
- •Patients of either sex aged between 18 – 70 years 4) Patients undergoing any type of standard palliative treatment for cancer except for pain management.
排除标准
- •Systemic diseases like uncontrolled hypertension, uncontrolled diabetes, heart diseases, Lung diseases, hepatic and renal dysfunctions.
- •Pregnancy and breast feeding women.
- •Cancer patients with ECOG more than
- •Patients with inability to comprehend and complete the proposed course study as per instructions.
结局指标
主要结局
Primary expected outcome will be reduction in pain and improvement in quality of life and overall associated symptoms in cancer patients
时间窗: 1 month drug intervention and 1 week follow up
次要结局
- Development of shodhit i e purified Bhanga churna in the management of improving quality of life in cancer patients specially as a analgesic agent(1 year)