NCT02580942

Brief Summary

The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases in Summer is effective in the treatment of chronic asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 12, 2017

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

July 30, 2015

Last Update Submit

December 10, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Total score Change from Baseline of Asthma Control Test

    Measured during the 6 week treatment period

Secondary Outcomes (2)

  • Cytokine levels of serum and induced sputum

    Measured during the 6 week treatment period

  • Lung function(FEV1, PVC, PEF)

    Measured during the 6 week treatment period

Study Arms (2)

Acupoint sticking therapy group

EXPERIMENTAL

36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.

Device: Magnetic stickersDrug: Chinese herbal medicine

Sham sticking therapy group

SHAM COMPARATOR

36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and sham magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.

Device: Sham magnetic stickersDrug: Chinese herbal medicine

Interventions

Magnetic stickersDEVICE

36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.

Also known as: Medical Magnet Points For Aching Pain
Acupoint sticking therapy group
Sham magnetic stickersDEVICE

36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and sham magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.

Also known as: Blank Points For Aching Pain
Sham sticking therapy group
Chinese herbal medicineDRUG

72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).

Also known as: Warm Yang Applicator Party
Acupoint sticking therapy groupSham sticking therapy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with mild-to-moderate remission phase of asthma
  • Patients who have given written informed consent

You may not qualify if:

  • Participation in another clinical trial 1 month prior to study entry
  • Participation received acupoint sticking of winter disease cured in summer
  • Use of corticosteroids 4 weeks prior to study entry
  • Patients who are allergic to therapeutic medicine
  • Female patients in lactation period, pregnancy or planning to get pregnant during the trial
  • Patients with severe primary diseases such as cancer, cardiovascular system, digestive system, kidney and hematopoietic system diseases
  • Patients with mental illness, acrasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital Affiliated Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Zhenhui Lu, doctor

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2015

First Posted

October 20, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

December 12, 2017

Record last verified: 2015-07

Locations

CN(1)