Pilot Randomized Controlled Trial to Evaluate add-on Effect of Amalaki (Phyllantus Emblica) and Haridra (Curcuma Longa) Along With Insulin on Glycaemic Control in Patients With Type-I Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in a insulin dose
研究概览
简要总结
Type-I diabetes mellitus (T1DM) is an autoimmune condition, in which the pancreas reduces/stops insulin production. Patients with T DM have to take insulin injections with every meal and also usually a long-acting preparation. In India, approximately 8.6 lakh people suffer from T1DM, and one in six young patients dies without a diagnosis.
Significant advancements are being made in the field of T1DM research, including stem cell therapy, islet cell transplantation, and immunotherapies, which hold promise for the future. However, so far, there is no known permanent cure for T1DM. Thus, treatment of T1DM aims at maintaining normal blood sugar levels through regular monitoring, insulin therapy, diet, and exercise.
Dietary constituents play an important role in the management of T1DM. Studies have shown that the fruits of Phyllanthus emblica Linn, colloquially known as Indian gooseberry (amla), and/or some of its important constituents (including gallic acid, gallotanin, ellagic acid, and corilagin) possess anti-diabetic actions through their antioxidant and free-radical-scavenging properties. Amla has also been reported to prevent or reduce hyperglycemia, cardiac complications, diabetic nephropathy, neuropathy, cataract genesis, and protein wasting. However, clinical trial data with human subjects are limited and preliminary.
Numerous studies also report that turmeric (Curcuma longa) has antioxidant, anti-inflammatory, and anti-diabetic activities and can lower lipid levels. The hypoglycaemic effect of turmeric may be due to increased peripheral glucose utilization, decreased hepatic glucose synthesis, and/or increased insulin secretion.
In Ayurveda, the combination of turmeric (haridra) and amla (amalaki) is strongly recommended for Prameha (Diabetes mellitus).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple
入排标准
- 年龄范围
- 10 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •K/C/O type-I DM for more than 1 year
- •Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
- •Parents provide consent and children providing assent for the study
排除标准
- •K/C/O type-I DM for more than 1 year
- •Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
- •Parents provide consent and children providing assent for the study
研究组 & 干预措施
Arm1-Only insulin treatment for type 1 Diabetes patients
Arm1:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient for 3 months.
干预措施: inj insulin to one group (Drug)
Arm1-Only insulin treatment for type 1 Diabetes patients
Arm1:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient for 3 months.
干预措施: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day (Drug)
Arm2-Insulin with Nisha-Amalaki tablets
Arm2:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient with Tab Nisha-Amalaki Dhootpapeshwar GMP certified 500 mg twice a day for 3 months.
干预措施: inj insulin to one group (Drug)
Arm2-Insulin with Nisha-Amalaki tablets
Arm2:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient with Tab Nisha-Amalaki Dhootpapeshwar GMP certified 500 mg twice a day for 3 months.
干预措施: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day (Drug)
结局指标
主要结局
Change in a insulin dose
时间窗: 3 months
Change in an insulin dose will be assessed at baseline and after 3 months of intervention by administering a standardised questionnaire.
Glycemic control (HbA1c)
时间窗: 3 months
Change in glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays.
次要结局
- Change in urinary parameter.(3 months)
- Change in Fat (%)(3 months)
- Change in Body composition.(3 months)
- Change in blood parameter-lipid profile.(3 months)
研究者
Dr. Anuradha Khadilkar
Consultant Pediatrician and Deputy Director
Hirabai Cowasji Jehangir Medical Research Institute
