Clinical Study on the Health Benefits of TT Compounded Asafoetida Powder in Adults with Diabetes Mellitus Type II
- Conditions
- Health Condition 1: K590- ConstipationHealth Condition 2: I10- Essential (primary) hypertensionHealth Condition 3: K297- Gastritis, unspecifiedHealth Condition 4: E785- Hyperlipidemia, unspecifiedHealth Condition 5: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/07/034802
- Lead Sponsor
- Mahesh Value Products PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 86
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method