Safety and efficacy of Ayukalash on high blood pressure and cholesterol.

Phase 4

Conditions: Health Condition 1: E784- Other hyperlipidemiaHealth Condition 2: I158- Other secondary hypertension

Registration Number: CTRI/2024/05/067632

Lead Sponsor: Med Pharma CRO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients suffering from Dyslipidemia and/or having Hypertension.

2.With/without treatment with lipid-lowering medications, lifestyle modifications, including diet or exercise and no contraindication to receiving Ayukalash.

3.Patients willing to give written informed consent and adhere to visit schedules and meet study requirements.

4.Patients willing to perform all study related procedures including the use of study medicine, allow the physical and other study related procedures (invasive & non-invasive) and willing to document symptoms and medication.

5.Agree to following instruction of do’s and don’ts in regular daily lifestyle.

6.Study participants are fit and no need any hospital administration.

Exclusion Criteria

1. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences and inability to carry out visits for the study.

2. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the study, and/or put the patient at significant risk (according to investigator’s [or delegate’s] judgment) if he/she participates in the study.

3. An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator [or delegate) might interfere with interpretation of the clinical study results.

4. Serious comorbid disease in which the life expectancy of the patient is shorter than the duration of the trial (e.g., acute systemic infection, cancer, or other serious illnesses).

5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of contraception (e.g., oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Lipid Profile (fasting or non-fasting lipid measurement, total cholesterol in combination with other lipid markers). <br/ ><br>2.High-sensitivity C-reactive protein (hs-CRP) <br/ ><br>3.Alanine aminotransferase <br/ ><br>4.Alkaline phosphatase <br/ ><br>5.Aspartate aminotransferase <br/ ><br>6.Cardiac Troponin <br/ ><br>7.Electrocardiogram (ECG)Timepoint: FROM BASELINE TILL 60 DAYS OF TREATMENT

Secondary Outcome Measures

Name	Time	Method
1.Changes in quality of life <br/ ><br>2.No incidence of Adverse events (AE) & Serious Adverse Events (SAE) during the study period <br/ ><br>3.Complete Blood Count (CBC) <br/ ><br>4.Liver Function Test (LFT) <br/ ><br>5.Kidney Function Test (KFT) <br/ ><br>FROM BASELINE TILL 60 DAYS OF TREATMENTTimepoint: FROM BASELINE TILL 60 DAYS OF TREATMENT