Phytochemical screening of ruta graveolens mother tincture and clinical effectiveness of ruta graveolens 30c in comparison with individualized homoeopathic medicine on colorectal cancer patients in respect to carcinoembryonic antigen:an open label non randomised clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tumor biomarker CEA will be evaluated
研究概览
简要总结
Following preliminary and detailed screening using specified selection (inclusion and exclusion) criteria, eligible patients will be recruited for the trial.
Each case will be studied properly through analysis and evaluation of symptoms and the symptoms will be matched against the symptoms of Ruta graveolens and if at least 50% symptoms would be present then it will be included in the study group 1 and if not then it will be included under study group 2.
Evaluation of symptoms as per homoeopathic literature and practice.
Selection of medicine in consultation with homoeopathic Materia Medica and therapeutics on the basis of instructions given by Dr. C. F. S. Hahnemann in the Organon of Medicine for individualized group.
Tumor biomarker CEA will be evaluated at baseline, 3 months and 6 months of post intervention therapy and will be compared in the both groups of patients . Scoring of Quality of Life of colorectal malignancy patient will be evaluated using EORTC QLQ –CR29 scoring system.
The response will be duly graded as per the EORTC QLQ- CR29 scoring system.
Observing the response of the patient through signs and symptoms and improvement in Quality of Life by EORTC QLQ- CR29 scoring system and reviewing of homoeopathic prescription on the basis of response of the patient.
Relevant clinical examination.
Relevant investigative procedures will be done as per need of the case.
Follow up will be done on regular basis (and as per need of the patients) for at least sixth months to ascertain the improvement.
The assessment of changes in value of Tumor Biomarker CEA will be done at baseline, after 3 months & 6 months of treatment.
The response of the patients will be observed and improvement in Quality of Life will be assessed with EORTC QLQ-CR29 scale at baseline, after 3 months and 6 months of treatment.
Group differences (independent observations) will be tested at baseline (to check compatibility), after 3 months and after 6 months (to check effectiveness). After the completion of the study dependent observations of continuous outcomes at baseline and at different points of time will also be compared using appropriate statistical tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of all genders, different religions and socioeconomic groups.
- •Age between 18-80 years.
- •Histologically confirmed Colorectal cancer patients.
- •In case the medicine does not provide relief or aggravate the patients condition and the disease progresses further, immediate care will be taken by providing the proper dose of medicine Patients having Colorectal Malignancy of any histological type at any stage except those mentioned under exclusion.
- •Patients who are otherwise untreated and have opted for homoeopathic treatment.
- •Patients who have already had Surgery, Radiotherapy or Chemotherapy but now intend to undergo homoeopathic treatment.
- •Patient willing to give written consent for participating in the study and complete follow-up during study.
排除标准
- •Patients who continue to be under Chemotherapy or Radiotherapy.
- •Pregnant and Lactating women.
- •Patients not willing to undergo any investigation, even after advised.
- •Individuals unwilling to get solely homoeopathic treatment.
- •Patients in the terminal stage of illness.
- •Diagnosed cases of unstable mental or psychiatric illness.
结局指标
主要结局
Tumor biomarker CEA will be evaluated
时间窗: At baseline, after 3 months and 6 months of treatment
次要结局
- The response of the patients will be observed and improvement in Quality of Life will be(assessed with EORTC QLQ-CR29 scale)
研究者
Dr Rashmi Rekha Naik
National Institute of Homoeopathy