CTRI/2021/07/034802已完成未知
An Open Label, Prospective, Randomised, Comparative, Two Arm, Cohort Based, Two Stage Clinical Study To Evaluate The Effectiveness, Safety And Health Benefits associated with the everyday consumption of TT Compounded Asafoetida Powder of Mahesh Value Products Pvt. Ltd. In Adult Subjects With Diabetes Mellitus Type II
Mahesh Value Products PvtLtd0 个研究点目标入组 86 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Must be prone to gastritis a minimum of 4 episodes per month
- •and must have had minimum one episode one week prior to screening. Subjects to score a total of Greater than or equal to 16 in the Amlapitta Symptoms Scale at screening.
- •5. Cohort 3-Constipation-Must be prone to constipation a minimum of 4 episodes per
- •month and must have had minimum one episode one week prior to screening. Subjects to score a total of Greater than or equal to 10 in the Constipation Severity Scale at screening.
- •6. Cohort 4-Hypertension-History of hypertension-systolic and or diastolic-a minimum of 3 months prior to screening. Must have elevated blood pressure-sitting, arm-at the time of screening.
- •7. Subjects who are on OHA or Insulin and or AYUSH remedies for the management of Diabetes Mellitus Type II
- •8. Subjects who willing to abstain from any remedies-allopathic, natural, home remedies-for relief or treatment of cohort indications.
- •9. Subjects who are willing to consume curd or buttermilk-animal and or plant milk-and are not lactose intolerant
- •10. Subject or LAR who is willing to give informed consent for participation, able to
- •comprehend and understand the responsibilities during treatment period and follow up period.
- •11. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1. Subjects with allergy, sensitivity or intolerance to the investigational product and or
- •the formulation ingredients.
- •2. Subjects on drugs, supplements, therapy regimens ââ?¬â??Allopathic or AYUSH-that cause or propagate cohort conditions namely gastritis or constipation
- •3. Subjects with a history of significant cardiovascular disease-eg-congestive heart failure New York Heart Association Grade III or IV, arrhythmia known to increase the risk of thromboembolic events-eg, atrial fibrillation-, coronary artery stent placement, angioplasty, and coronary artery bypass grafting-Coronary artery bypass graft -CABG-, Percutaneous transluminal coronary angioplasty-PTCA-
- •4. Subjects who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study.
- •5. Subjects with complete cancer remission less than 3 years prior to the date of screening.
- •6. Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology of said indication
- •7. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
- •8. Subjects who are on anti-depressants, anti-psychotics.
- •9. Any significant medical condition -e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-any medical condition that is unstable or poorly controlled or other factor -e.g.-planned relocation-that the Investigator felt would interfere with study evaluations and study participation.
- •10. Subjects who have participated in any clinical study within 3 months from the date of enrolment.
- •11. Females who are pregnant or lactating or planning to become pregnant during the study period
- •12. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •13. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study
研究者
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