CLINICAL TRIALS

Title

Effectiveness of nifedipine, labetalol, and hydralazine as emergency antihypertension in severe preeclampsia

Methodology

Randomized, controlled trial, double blind study

Study duration

Estimated duration for the main protocol (e.g. from start of screening to last subject processed and finishing the study) is approximately 1 year

Study Centers

Four hospitals at Riau Province of Indonesia:

1.    Arifin Achmad Hospital

2.    Tengku Rafian Siak Sri Indrapura Hospital

3.    Dumai Hospital

4.    Bengkalis Hospital

Objectives

Primary Objective: to evaluate the efficacy of nifedipine vs labetalol vs hydralazine in lowering blood pressure during hypertensive emergencies in severe preeclampsia

Number of Subjects

60 randomized patients

Diagnosis and Main Inclusion Criteria

The severe preeclampsia was defined as pregnant women with systolic blood pressure ≥160 mmHg or diastolic ≥110 mmHg that persisted for 15 minutes.

Inclusion criteria were:

(a) severe preeclampsia patient with 28–34-week gestation;

(b) had live foetus;

(c) upper arm circumference 23.5–33 cm;

(d) haemoglobin level at least 10.5 g/dL.

All severe preeclampsia patients with decreased consciousness; had complications such as eclampsia, HELLP syndrome, kidney failure, or acute pulmonary oedema; in labour; received antihypertensive therapy in the last 12 hours; had an allergy to the trial drugs; and had asthma and heart disease were excluded.

The drop-out criteria were: the mother experienced allergy symptoms, had labour, or emergency symptoms such as placental abruption and foetal distress during the study.

Study Product, Dose, Route, Regimen

All severe preeclampsia patients who came to the hospitals were subjected to anamnesis, physical and laboratories examination and then selected based on predetermined inclusion criteria. Blood pressure measurements were carried out using a digital sphygmomanometer with the Omron 7600T brand. The patient was asked to sit and rest for 10 minutes, the measurement was conducted twice on the arm with a distance period of 15 minutes, and the data taken was the second measurement. If the patients met the requirements, they were asked to participate in the study and all patients have to sign the written informed consent before the enrolment. The assigned group was computerized randomized using Randomizer software.

Furthermore, 60 kits containing experimental drugs have been made available. To optimize double blinding, each kit was filled with three tablet drugs and three injection drugs. For example, for nifedipine kit, it contained 3 nifedipine tablets and 3 ampoules of placebo liquid. Each drug was administered 3 doses within 60 minutes (i.e., 20 minutes interval). Each dose of the drug contained: oral nifedipine (20 mg), intravenous labetalol (20 mg in 10 ml of sodium chloride 0.9%) and intravenous hydralazine (10 mg in 10 ml of sodium chloride 0.9%). Health care workers and patients did not know the drugs contained in the kit. Health workers were instructed to administrate one pair of drugs (i.e., one tablet and one ampoule injection; this contained one drug and one placebo) for each time. The blood pressure was assessed 20 minutes after each administration. If the blood pressure did not meet the MAP target (lowering 20% MAP), the second pair of drugs (one tablet and one ampoule injection) was given and the blood pressure was reassessed in 20 minutes until the third pair of the drugs. The technique of administering magnesium sulphate and dexamethasone was uniform in all patients. If the MAP was nor reached after the third dose, the patient was treated with other drugs and excluded from the final analysis and the patient

Statistical Methodology

The end points of this study were: (a) systolic blood pressure; (b) diastolic blood pressure; (c) MAP; and (d) side effects. The blood pressure was measured seven times as follows: (1) minute 0 (pre-treatment); (2) 20 min post-first dose; (3) 20 min post-second dose (i.e., 40 min post-first dose); (4) 20 min post- third dose (i.e., 60 min post-first dose); (5) 2 h post-first dose; (6) 4 h post-first dose; and (7) 6 h post- first dose.

Title

Effectiveness of metformin, DLBS 3233 and Vaccinium myrtillus extract to improve the Rotterdam criteria and HOMA-IR score in women with chronic polycystic ovarian syndrome

Methodology

Randomized, controlled trial, double blind study

Study duration

Estimated duration for the main protocol (e.g. from start of screening to last subject processed and finishing the study) is approximately 1 year

Study Centers

hospitals at Riau Province of Indonesia:

1.    Arifin Achmad Hospital

Objectives

Primary Objective: to evaluate change in characteristic of Rotterdam and HOMA-IR In patient with chronic polycystic ovarial syndrome

Number of Subjects

39 randomized patients

Diagnosis and Main Inclusion Criteria

Inclusion standards

1. All patients who satisfied the Rotterdam PCOS criteria for chronic polycystic ovarian syndrome, which includes oligomenorrhea or amenorrhea and at least one of the two symptoms of hyperandrogenism (clinical or biochemical proof of it) or polycystic ovaries on ultrasound.

2. 18–44 is the productive age range.

3. Ready to take part in research.

4. Knowledge of and willingness to follow research protocol

5. Written permission

HOMA-IR > 2.0 6.

Exclusion standards

1. People with comorbid conditions

2. Treatment for insulin sensitivity within three months of the eight-week study period or during that time.

3. Drug hypersensitivity reactions that are well-known.

4. A body mass index that is 20 or higher.

dropout standards

1. The mother experienced previously unknown allergic and hypoglycemic symptoms during the course of the trial.

2. The woman experienced emergency symptoms throughout the course of the trial, including unconsciousness, hypoglycemia, allergy, hypotension, and shortness of breath.

3. Women who were pregnant at the time of the study.

Study Product, Dose, Route, Regimen

This study compares the effects of the treatment groups metformin, DLBS 3233, and Vaccinium myrtillus extract on changes in the characteristics of Rotterdam and HOMA-IR in participants with chronic polycystic ovary syndrome in a randomized controlled trial that is analytical, prospective, and comparative in nature.

All populations that met the research inclusion requirements, were exempt from the exclusion criteria, and gave their consent to be included in the study were successively sampled. The sampling method uses random groupings, and grouping is carried out systematically. Names of respondents are entered based on numbers, and groups are chosen based on numbers that have been randomly assigned.

At the Arifin Achmad Hospital in the province of Riau, this study was carried out. Visitors to the  analyzed, given a diagnostic physical exam, and submitted to laboratory tests before being chosen based on the predefined Rotterdam criteria. The HOMA-IR measurements were performed in a lab evaluation.

Prior to the assessment, patients are asked to fast for 6 to 8 hours. When a situation qualifies for study participation, the research is discussed and the patient is prompted to give written consent. Using Randomizer software, the group division was randomly assigned in a controlled and mechanized manner.

39 kits containing experimental medications have also been made available. The medications in the kit were kept a secret from the researchers and the patients in order to maximize double blinding. The person who has been diagnosed will have their HOMA-IR levels tested before taking the medication; the cost of this test is covered by the researcher working in a standardized lab.

The healthcare professionals were told to provide the medication for three months at a fixed dose and taken daily after receiving the findings of the HOMA-IR levels in accordance with the criteria. Patients were given a special spot in their own room, were not required to wait in line, and received care from the same pharmacist until the completion of the trial.

After taking the medication for three months, the HOMA-IR was evaluated (again in a standard laboratory), and the Rotterdam criteria were assessed. The patient's unique medical record has comprehensive documentation of all activities.

The respondent will continue to be monitored and given a daily journal while using drugs. daily regarding the concerns they see, but if there are indications of an emergency, the response must inform the officer right away, and the medicine will be halted right away.

The patient is not charged for any examination costs or medications, and all costs are covered by the researcher. The health officer then documents the respondent's information in accordance with the predetermined coding kit, including monitoring blood sugar, the patient's subjective and objective complaints, as well as the respondent's medical record number for additional data analysis. The respondent is then required to be monitored every month for three months following the administration of medication. All responders received the drug administration method in a uniform manner in accordance with the procedure.

Statistical Methodology

Age, arm circumference, Homa IR, body weight, BMI, chest circumference, side symptoms (both subjective and objective), and Rotterdam criteria