Standard Artemisinin Combination Therapy (ACT) being used as currently approved antimalarial therapy at WHO and manufacturer recommended dosage. The specific ACT used is artemether-lumefantrine (Coartem). Form is scored tablets that each contain 20 mg artemether and 120 mg lumefantrine.
Tablets per dose, are given BID for 3 days as shown below:
Coartem tablets/dose by bodyweight; tablets/day morning and evening for total of 6 doses over 3 days
Body weight (kg) and Tablets: 5 to <15 kg, 1 tab; 15 to <25 kg, 2 tabs; 25 to <35 kg, 3 tabs; 35 kg and over, 4 tabs.

Dried leaf Artemisia annua (DLA) from 0.25-1 g total/day, BID. DLA is given as 500 mg tablets according to body weight (see below) for 5 days.
DLA tablets/dose by bodyweight; tablets/day, morning and evening, for total of 10 doses over 5 days.
Body weight (kg) and tablets/dose:
For DLA1x: 5 to < 15 kg, 1/4 tab; 15-30 kg, 1/2 tab; 1/2>30 kg, 1 tab.

Dried leaf Artemisia annua (DLA) from 0.5-2 g total/day, BID. DLA is given as 500 mg tablets according to body weight (see below) for 5 days.
DLA tablets/dose by bodyweight; tablets/day, morning and evening, for total of 10 doses over 5 days.
Body weight (kg) and tablets/dose:
For DLA2x: 5 to < 15 kg, 1/2 tab; 15-30 kg, 1 tab; >30 kg, 2 tabs.

Malaria

Current approved drug for treating malaria

Experimental drug treatment, single dose.

DLA1

Experimental drug treatment, doubled the dose of DLA1.

DLA2

Rwanguba Reference Hospital

Dried Leaf Artemisia (DLA) Compared to Artemisinin Combination Therapy (ACT) vs Malaria

Efficacy of Dried Leaf Artemisia (DLA) Versus Coartem (ACT): A Randomized Controlled Clinical Trial for Comparing DLA vs. ACT to Treat Malaria

Use microscopy and qPCR to compare change in gametocyte carriage among the 3 treatment arms.

Use microscopy to measure and compare parasitemia elimination in the blood of patients among the 3 treatment arms.

Compare patient side effects observationally measured among the 3 treatment arms.

Pamela Weathers

Professor of Biology and Biotechnology

Worcester Polytechnic Institute

Plesion International, Coatesville, PA

HEAL Africa Hospital, Goma, Democratic Republic of Congo

Rwanguba Reference Hospital, Rwanguba, Democratic Republic of Congo

Nail Abnormalities

apply nail gel on affected nails twice daily for 2 months

Nail gel

Siriraj Hospital, Mahidol University

Pilot Study of Efficacy of Nail Gel in Finger Nail Surface Abnormality

Pilot Study of Efficacy of Nail Gel Containing Artemisia Abrotanum Extract and Glycerin in Finger Nail Surface Abnormality

Number of nails of each participant with change/improvement nail surface using clinical assessment

Number of nails of each participant with change/improvement nail surface using bioengineering measurement

Number of nails of each participant with the increase of nail hydration using bioengineering measurement

good patients's satisfaction outcome by self-questionnaire

Mahidol University

A series of moxibustion sessions within six weeks from baseline with adjuvant chemotherapy.

Participants who will be allocated to waitlist will receive no moxibustion treatments throughout the 6 weeks while receiving adjuvant chemotherapy

Cancer

In the moxibustion treatment group, 3 moxibustion, 3 acupoints(CV12, CV8, CV54) will be heated with indirected moxibustion.
The moxibustion will be removed when the patient feel hotness and require remove them

Moxibustion

Click here for more information about this study:A Pilot study to estimate the efficacy of moxibustion stimulation at abdominal acupoints on quality of life in cancer patients

Deagu Hanny University Medical center

Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer

A Pilot Study to Estimate the Efficacy of Moxibustion Stimulation at Abdominal Acupoints on Quality of Life in Cancer Patients Under Chemotherapy

lymphocyte panel(CD3,4,8,19,26), WBC, Differential count

Hyun jung, Jung

assistant professor

The Comprehensive and Integrative Medicine Institute of South Korea

3 or 4 tablets of Eurartesim™, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.
Administration of Eurartesim will be in fed condition following a high-fat/low-Kcal meal.

4 tablets of Riamet® on Day -1 evening, 4 tablets of Riamet® bid (with an interval of 12 ± 0.5 h), in the morning and in the evening of Day 1 and Day 2, 4 tablets of Riamet® in the morning of Day 3.
Administration of Riamet® will be in fed condition following a high-fat/low-Kcal meal.

3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3.
Administration will be in the morning, in fed condition, following a high-fat/low-Kcal meal
1 tablet of Izilox® (400 mg moxifloxacin) in fed condition following a high-fat/low-Kcal meal, on Day 4 morning.

3 or 4 tablets of Eurartesim™, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.
Administration of Eurartesim will be in fed condition following a high-fat/high-Kcal meal.

3 or 4 tablets of Eurartesim™, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.
Administration of Eurartesim will be in fasting condition.

3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3.
Administration will be in the morning, in fasting condition.
1 tablet of Izilox® (400 mg moxifloxacin) in fed condition following a high-fat/low-Kcal meal, on Day 4 morning.

Malaria, Falciparum

3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3

Eurartesim™

4 tablets of Riamet® (20mg artemether/120mg lumefantrine) on Day -1 evening, 4 tablets of Riamet® bid (with an interval of 12 ± 0.5 h), in the morning and in the evening of Day 1 and Day 2, 4 tablets of Riamet® in the morning of Day 3.

Riamet®

3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3.
1 tablet of Izilox® (400 mg moxifloxacin) on Day 4 morning.

Placebo and finally Moxifloxacin

3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.

3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3.
1 tablet of Izilox® (400 mg moxifloxacin)on Day 4 morning.

SGS aster s.a.s

Safety Study on the Effect of Eurartesim™ on QT/QTc Interval Compared to Riamet in Healthy Volunteers

Phase I, Randomized, Parallel Group Study to Evaluate the Effect of Multiple Oral Doses of Eurartesim on the QT/QTc Interval Compared to Riamet, Placebo and Moxifloxacin in Healthy Male and Female Volunteers

Group 1,4 and 5 (Day -1: pre-dose, each hour till 13h post-dose. Day 1: pre-dose, 1, 2, 3, 4, 5, and 6 h post-dose. Day 3: pre-dose, each hour till 13h post-dose and then 24h).
Group 2 (Day -2: pre-dose, each hour till 13h post-dose and then 24h. Day 3: pre-dose, each hour till 13h post-dose and then 24h).
Group 3 and 6 (Day -1: pre-dose, each hour till 13h post-dose. Day 1: pre-dose, 1, 2, 3, 4, 6, 8, 12 and 24h post-dose. Day 3: pre-dose, pre-dose, each hour till 13h post-dose. Day 4: pre-dose, 1, 2, 3, 4, 6, 8, 12 and 24h post-dose).

To evaluate the impact of a therapeutic dose of Eurartesim™ under different food intake conditions on the cardiac activity, as expressed by ECG parameters.

To evaluate the impact of high-fat/high-Kcal or high-fat/low-Kcal meals on the overall relative bioavailability of Eurartesim™ in respect to no food.

To compare, within the Eurartesim™ groups, the PK profiles and the QT intervals of subjects with a body weight below or equal and above 75kg

To evaluate the relationship between the PK parameters of Dihydroartemisinin and Piperaquine and the ECG parameters

To assess the safety and tolerability of Eurartesim™ under different food intake conditions in healthy subjects

artemisia/protiplesňový

Dried Leaf Artemisia (DLA) Compared to Artemisinin Combination Therapy (ACT) vs Malaria

Pilot Study of Efficacy of Nail Gel in Finger Nail Surface Abnormality

Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer

Safety Study on the Effect of Eurartesim™ on QT/QTc Interval Compared to Riamet in Healthy Volunteers

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