PROSPECTIVE CLINICAL STUDY TO VERIFY THE EFFECT OF HYDRANGEA ARBORESCENS IN CASES OF RENAL CALCULI ASSESSED BY GUYS STONE SCORE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To understand the effectiveness of Hydrangea arborescens in cases of renal calculi. To study of Sign & Symptoms of Hydrangea arborescens related to renal calculi. To assess the clinical utility of GUY’S stones core.
研究概览
简要总结
THE MATERIAL UTILIZED FOR THE STUDY o Informed consent i.e., to be signed by every patient. o A specialized designed Case – taking Performa. (Note – all the records, forms and reports of the patient will be kept confidential.) o Suitable Materia Medica books, journals, articles, medicine and surgery books, information from authentic online sites. o The medication will be provided by the dispensary of Sainath Homoeopathic Hospital and obtained from an authentic homoeopathic pharmacy.
METHOD OF COLLECTION OF DATA The study shall be performed in following ways: o Type of study: Qualitative, Interventional / Clinical,Prospective study o Sample size:40cases o Duration:9 months o Sample Method: Random sampling
INTERVENTION GUIDELINES: o Individualized Homoeopathic Medicine selection is based on the Totality of Symptoms for each caseas their similimum and Hydrangea arborescence is given to suitable patient. o Potency, dose, and repetition are determined by the patient’s susceptibility.
CASE-TAKING PROCEDURE o Guidelines for case taking, as outlined by Dr. Hahnemann in aphorisms §83- §104(15), are adhered to when using the Case Performa at Sainath Homoeopathic Hospital.
SELECTION OF MEDICINE o Hydrangea arborescence medicine will be given to suitable patients.
SELECTION OF POTENCY o According to pathology and guideline related to selection of potency given under organon of medicine and as per requirement of patient.
DOSE & REPETITION o The administration of the remedy will adhere to the principles outlined in the Homoeopathic Organon of Medicine (15) and as per patient requirement.
ROUTE OF ADMINISTRATION OF MEDICINE o All medications will be administered orally.
FOLLOW UP AND MONITORING o Follow–up of each case will be taken at 15 days or as per requirement for patient o USG performed at three-month intervals.
RECORDS o All the records will be maintained as per standard procedure of institution
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Pre- diagnosed and Diagnosed cases of renal calculi.
- •Patient who are voluntarily taking Homoeopathic Medicines and Patients who voluntarily participate in research.
排除标准
- •Age below18 and above 45years.
- •Patient having any other systemic disease example Diabetes Mellitus, Hypertension, Hyperparathyroidism etc.
- •Patient having any other renal pathology other than renal calculi like Acute kidney injury, Acute Renal failure, chronic Renal failure, Glomerulonephritis etc.
- •Patient having terminal disease like Cancer, HIV etc.
- •Individual utilizing Allopathic medicine/ any other pharmacological Treatment other than homeopathy are excluded.
- •Pregnant women and lactating women are excluded.
结局指标
主要结局
To understand the effectiveness of Hydrangea arborescens in cases of renal calculi. To study of Sign & Symptoms of Hydrangea arborescens related to renal calculi. To assess the clinical utility of GUY’S stones core.
时间窗: this will be achieved within 12 months
次要结局
- For the effective assessment and evaluation, disease intensity scores will also be(maintained according to Guy’s Stone Score.)
研究者
Dr Drashti Gadhiya
Rajkot Homoeopathic Medical College, Parul University