Health Condition 1: K590- Constipation Health Condition 2: I10- Essential (primary) hypertension Health Condition 3: K297- Gastritis, unspecified Health Condition 4: E785- Hyperlipidemia, unspecified Health Condition 5: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: TT Compounded Asafoetida Power: Dose 1g of TT Compounded Asafoetida Powder in 1 glass-approx 300ml-of buttermilk and consumed once a day
Dosage : Once a day for 96 days
Route of Admi
Sponsors
Mahesh Value Products PvtLtd
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1 Day 1to 48 FBG 10% reduction PPG 10% reduction HbA1C 10% reduction Dyslipidemia 10% reduction Amlapitta Symptoms Scale 25% reduction Constipation Severity Scale 25% reduction Hypertension : Improvement of 5 mmHg Stage 2 Day 1to 96 FBG 125 mg/dL or 20% reduction PPG 140 - 199 mg/dL or 20% reduction HbA1C 6.4% A1C levels or 20% reduction Dyslipidemia 20% reduction Amlapitta Symptoms Scale Score of 8 Constipation Severity Scale Score of 5 Hypertension Normal BPTimepoint: Stage 1 Day 1to 48 FBG Day 1, Day 48 PPG Day 1, Day 48 HbA1C Day 1, Day 48 Dyslipidemia Day 1, Day 48 Amlapitta Symptoms Scale Day 1, Day 48 Constipation Severity Scale Day 1, Day 48 Hypertension : Day 1, Day 48 Stage 2 Day 1to 96 FBG Day 1, Day 96 PPG Day 1, Day 96 HbA1C Day 1, Day 96 Dyslipidemia Day 1, Day 96 Amlapitta Symptoms Scale Day 1, Day 96 Constipation Severity Scale Day 1, Day 96 Hypertension Day 1, Day 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare Research and Development India Private Limited
Outcome results
None listed