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临床试验/CTRI/2024/04/066492
CTRI/2024/04/066492尚未招募2 期

A pilot study of metabolic syndrome metasynthesis of holistic medicine(homoeopathy) and integrative medicine.

Metropolitan Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Waist circumference- ≥ 102 cm (40 inches) in males and ≥88 cm (35 inches) in females.

研究概览

简要总结

This pilot study is an non randomized , active controlled trial to test the effectiveness of homoeopathic medicines and integrative medicine on metabolic syndrome. In this pilot study, we aim to study a minimum of 50 patients within a frame of 6 months where they will be observed for 6 months with follow-up after every 2 weeks. Patients will be selected based upon inclusion criteria if they are presenting with any 3 out of 5 criteria. We planned on dividing patients into 2 groups, on one we will administer homoeopathic remedies based on the totality of symptoms under the miasmatic background on the basis of homoeopathic philosophy. For another group we will consider Integrative medicine mainly focusing on patients who are coming to our study site with ongoing treatment with modern medicines, where we will only administer homoeopathic medicine according to individualization. We will not be giving any allopathic medicines. General Management will be advised through- DASH diet / low GI Diet / MUFAs / n-6 VLC-PUFAs and exercises. Data collection and instrument used- (i) Waist circumference- To be measured with a measuring tape by placing tape in a horizontal plane around abdomen at the level of iliac crest. Before measuring ensure the tape is sung but does not compress the skin and is parallel to the floor. Measurement is made at the end of normal expiration in centimeters or inches.(ii) Blood pressure- To be measured with a sphygmomanometer & stethoscope.(iii) Lab tests such as(only one from each of these, as per patients needs will be done)-(a)Blood sugar level- Fasting glucose test/ HbA1C test/ Oral Glucose Tolerance Test. (b)Triglyceride level- Triglycerides test (TGL) / Lipid profile test. (c)Low HDL-C level- High Density lipoprotein Cholesterol test(HDL-C test) / Lipid profile test. Lab tests will be done twice, before administration of medicine and at the end of 6 months or when the patient gets better(may vary).Individualized homoeopathic medicines, potency of the medicines, doses, and form of administration on patients will be recorded. In case of integrative approach, a list of conventional group of medicines acting along homoeopathic medicines in patients will be recorded. The primary outcome measures will be Waist circumference- ≥ 102 cm (40 inches) in males and ≥88 cm (35 inches) in females; Hypertension- ≥ 130/85 mm of hg; Blood sugar level- Fasting glucose test or HbA1C test or Oral Glucose Tolerance Test; Triglyceride level- Triglycerides test (TGL) or Lipid profile test; Low HDL-C level- High Density lipoprotein Cholesterol test(HDL-C test) or Lipid profile test; at 6 months of time period and secondary outcome measures will be Waist circumference- ≥ 102 cm (40 inches) in males and ≥88 cm (35 inches) in females; Hypertension- ≥ 130/85 mm of hg; at every 2 weeks for 6 months &  Blood sugar level- Fasting glucose test or HbA1C test or Oral Glucose Tolerance Test; Triglyceride level- Triglycerides test (TGL) or Lipid profile test; Low HDL-C level- High Density lipoprotein Cholesterol test(HDL-C test) or Lipid profile test; will be done twice before administration of homoeopathic medicine and after 6 months of administration of homoeopathic medicine.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • We will be considering patients who can satisfy any 3 out of these 5 criteria as per The National Cholesterol Education Program: Adult Treatment Panel III(NCEP: ATP III) later modified by American Heart Association(AHA) & National Heart, Lung and Blood Institute(NHLBI- 1)Abdominal obesity- ≥ 102 cm (40 inches) in males and ≥ 88 cm (35 inches) in females.
  • Hypertension- ≥130 mm Hg systolic blood pressure ; ≥85 mm Hg diastolic blood pressure or under antihypertensive drug treatment in a patient with a history of hypertension.
  • Hyperglycemia- ≥100 mg/dL or under drug treatment for elevated glucose.
  • Hypertriglyceridemia- ≥150 mg/dL (1.7mmol/ L) or under drug treatment for elevated triglycerides.
  • Low high density lipoprotien cholesterol levels- less than 40 mg/dL in males and less then 50 mg/dL in females or under drug treatment for reduced HDL-C levels.

排除标准

  • Patients suffering from AIDS, cancer along with metabolic syndrome are excluded.
  • Pregnant & lactating women are excluded.
  • Patients with life threatening diagnosed heart and neurological disorders.

结局指标

主要结局

Waist circumference- ≥ 102 cm (40 inches) in males and ≥88 cm (35 inches) in females.

时间窗: 6 months

Hypertension- ≥ 130/85 mm of hg

时间窗: 6 months

Blood sugar level- Fasting glucose test or HbA1C test or Oral Glucose Tolerance Test.

时间窗: 6 months

Triglyceride level- Triglycerides test (TGL) or Lipid profile test.

时间窗: 6 months

Low HDL-C level- High Density lipoprotein Cholesterol test(HDL-C test) or Lipid profile test.

时间窗: 6 months

次要结局

  • Waist circumference- ≥ 102 cm (40 inches) in males and ≥88 cm (35 inches) in females.(Hypertension- ≥ 130/85 mm of hg)

研究者

发起方
Metropolitan Homoeopathic Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Ankush Singha

Metropolitan Homeopathic Medical College and Hospital

研究点 (1)

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