Phytochemical screening of Gymnema sylvestre mother tincture and validation of the hypoglycemic effect of Gymnema sylvestre mother tincture, 6C and 30C in patients of Diabetes mellitus type 2 with HbA1c parameter: An open label randomized controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
samples will be selected following preliminary and detailed screening using specified selection criteria. Inclusion and exclusion criteria are strictly followed, eligible patients will be recruited for the trial . General (Non-medicinal) management including appropriate diet and regimen will be advised. subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. baseline data will be compared with the data obtained in 3 months or 6 months. Each case will be studied properly through analysis and evaluation of symptoms and the symptoms will be matched against the symptoms of Gymnema sylvestre. Response of the patients will be observed and improvement in clinical symptoms with checking of Glycosylated hemoglobin (HbA1c), post prandial blood sugar (PPBS) and fasting blood sugar (FBS) level in type 2 diabetes mellitus at Baseline, 3 month and 6 months of treatment.
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of different religions and socioeconomic groups.
- •Patients who are untreated before and have opted for homoeopathic treatment.
- •Patient who have already had other medication but now intend to undergo homoeopathic treatment.
- •Confirmed cases of diabetes mellitus type 2 patients.
- •Patients with Glycosylated haemoglobin (HbA1c) is equal to or greater than 6.5 %, Post prandial blood sugar (PPBS) is equal to or greater than 11.1 mmol/l (200 mg/dl) and Fasting blood sugar (FBS) is equal to or greater than 7.0 mmol/l (126 mg/dl) in type 2 diabetes mellitus.
- •Patient willing to undergo laboratory investigations whenever required.
- •Patient willing to give written consent for participating in the study and complete follow-up during study.
排除标准
- •Patient taking medicines for diabetes mellitus type 2 complications.
- •Patients suffering from any life threatening illness or any major complication of diabetes mellitus type 2 and other associated co-morbities.
- •Patients not willing to undergo any investigations, even after advised.
- •Patients whose blood glucose level were not controlled within 3 months after giving Homoeopathic medicine Gymnema sylvestre mother tincture or Gymnema sylvestre 6C or Gymnema sylvestre 30C.
结局指标
主要结局
Glycosylated hemoglobin (HbA1c)
时间窗: at baseline, 3 | months and 6 months.
次要结局
- Post prandial blood sugar (PPBS) & Fasting blood sugar (FBS).(at baseline, 3 months & 6 months.)
研究者
Dr Irfan Munir
National Institute of Homoeopathy