The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation

PHASE2CompletedINTERVENTIONAL
Enrollment

1,075

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2014

Conditions
Constipation
Interventions
DEVICE

electro-acupuncture

Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 30to70mm into bilateral ST25 and SP14 vertically until piercing the abdominal muscle layer.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 10/50 Hz and electric current 0.1-1.0mA. The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are inserted 25-30mm and then twirling lifting and thrusting for 3 times.Local sour and heavy feeling is appropriate dose. Steady small twirling lifting and thrusting 3 times in all. 30 min/per day/per session.During the 8 weeks treatment, the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.

DEVICE

sham electro-acupuncture

Procedure:sham electro-acupuncture;Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37).Sham points location:20mm away from ST25,middle of Spleen and Stomach Channel;30mm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance:The needle is inserted with needle of 0.30×25mm by 3-5mm. No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,10/50 Hz and electric current 0.5mA.The mental wire has been cut off with a same outlook as the treatment group.The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.

Trial Locations (1)

100700

Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing

All Listed Sponsors
collaborator

Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

lead

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

NCT01726504 - The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation | Biotech Hunter | Biotech Hunter