The Effect Evaluation of Laser Acupuncture in Obesity
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Status
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
UJI KLINIS: NCT01975168
BioSeek: nct01975168
Kata kunci
Abstrak
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.
tanggal
| Terakhir Diverifikasi: | 10/31/2013 |
| Pertama Dikirim: | 10/22/2013 |
| Perkiraan Pendaftaran Telah Dikirim: | 10/31/2013 |
| Pertama Diposting: | 11/02/2013 |
| Pembaruan Terakhir Dikirim: | 11/04/2013 |
| Pembaruan Terakhir Diposting: | 11/05/2013 |
| Tanggal Mulai Studi Sebenarnya: | 08/31/2013 |
| Perkiraan Tanggal Penyelesaian Utama: | 06/30/2015 |
| Perkiraan Tanggal Penyelesaian Studi: | 06/30/2015 |
Kondisi atau penyakit
Obesity
Intervensi / pengobatan
Device: Handylaser Trion laser acupuncture
Tahap
-
Kelompok Lengan
| Lengan | Intervensi / pengobatan |
|---|---|
| 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 |
Kriteria kelayakan
| Usia yang Layak untuk Belajar | 20 Years Untuk 20 Years |
| Jenis Kelamin yang Layak untuk Belajar | All |
| Menerima Relawan Sehat | Iya |
| Kriteria | 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 |
Hasil
Ukuran Hasil Utama
1. body composition [12 weeks]
body weight
Ukuran Hasil Sekunder
1. body mass index [12 weeks]
Ukuran Hasil Lainnya
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]
