The Effect Evaluation of Laser Acupuncture in Obesity
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Rėmėjai
Kaohsiung Medical University Chung-Ho Memorial Hospital
KLINIKINIS TYRIMAS: NCT01975168
BioSeek: nct01975168
Raktažodžiai
Santrauka
A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2 groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2 receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds every time, 3 times per week. The measurements of outcomes are performed in the beginning, weekly during treatment, and monthly after treatment for 3 months.
Datos
| Paskutinį kartą patikrinta: | 10/31/2013 |
| Pirmasis pateikimas: | 10/22/2013 |
| Numatytas registravimas pateiktas: | 10/31/2013 |
| Pirmas paskelbtas: | 11/02/2013 |
| Paskutinis atnaujinimas pateiktas: | 11/04/2013 |
| Paskutinis atnaujinimas paskelbtas: | 11/05/2013 |
| Faktinė studijų pradžios data: | 08/31/2013 |
| Numatoma pirminio užbaigimo data: | 06/30/2015 |
| Numatoma studijų užbaigimo data: | 06/30/2015 |
Būklė ar liga
Obesity
Intervencija / gydymas
Device: Handylaser Trion laser acupuncture
Fazė
-
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: Group 1 arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks | |
| Sham Comparator: Group 2 arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 20 Years Į 20 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male Exclusion Criteria: - Pathmakers user - Epilepsy history - Pregnancy - Immuno-inhibiting agents user - Malignancy - Skin contacted disease - Weight controlled agents user during trial period - Eating disorder |
Rezultatas
Pirminės rezultatų priemonės
1. body composition [12 weeks]
body weight
Antrinės rezultatų priemonės
1. body mass index [12 weeks]
Kitos rezultato priemonės
1. waist circumference [12 weeks]
2. hip circumference [12 weeks]
3. body fat [12 weeks]
4. blood pressure [12 weeks]
5. heart rate [12 weeks]
