NCT02035111

Brief Summary

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
947

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

20 active sites

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

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

1.1 years

First QC Date

January 10, 2014

Last Update Submit

April 13, 2016

Conditions

Migraine

Keywords

MigraineTianshu capsule

Outcome Measures

Primary Outcomes (1)

  • Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline

    -4w,0,4w,8w,12w,16w

Secondary Outcomes (6)

  • Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline.

    -4w,0,4w,8w,12w,16w

  • Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline.

    -4w,0,4w,8w,12w,16w

  • Change in the days using acute therapy of Migraine Per 4 weeks at Week 16 from baseline.

    -4w,0,4w,8w,12w,16w

  • Proportion of subjects whose number or days of migraine attacks reduce at least 50%.

    -4w,0,4w,8w,12w,16w

  • Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline.

    -4w,0,4w,8w,12w,16w

  • +1 more secondary outcomes

Study Arms (2)

Tianshu capsule

EXPERIMENTAL

Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks.

Drug: Tianshu capsule

Sugar pill

PLACEBO COMPARATOR

Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks.

Drug: Sugar pill

Interventions

Tianshu capsuleDRUG
Tianshu capsule
Sugar pillDRUG
Sugar pill

Eligibility Criteria

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

You may qualify if:

  • Must meet the Migraine diagnosis.
  • Age of onset should be before age 50 years.
  • Migraine must have been occurring for 1 year preceding entry into the trial.
  • The number of migraine attack should be no less than 6 for a period of 3 months prior to Screening stage.
  • The number of migraine days is to be 2-8 for a period of 1 month prior to screening for entry into the trial.
  • Migraine days should be less than 15 for a period of 1 month prior to screening for entry into the trial.
  • Ages 18-65.
  • Participant can understand and complete the Headache diary.
  • All participants signed the informed consent.

You may not qualify if:

  • Other migraine prophylactic medication is continued 3 months prior to the drug trial.
  • Participants who have taken Tianshu capsule during 1 month prior to Screening stage.
  • The number of acute treatment for migraine is more than 10 per month.
  • Participants who have taken antipsychotics or antidepressant medications (unless only for migraine prophylaxis) during the previous 3 months.
  • Participants who abuse alcohol or other drugs.
  • Participants who are resistant to all acute migraine drugs prescribed optimally.
  • hypotension or uncontrolled hypertension.
  • Severe infections.
  • Malignancy.
  • Significant medical history of such as cardiac disease, cerebrovascular disease, liver disease, nephropathy etc.
  • Known allergies or serious side effects with Tianshu capsule in the past.
  • Breastfeeding, pregnant and potentially fertile women participant.
  • History of cluster headaches, tension-type headache, vascular headache with non-migraine, drug - dependence headache.
  • Secondary headaches, including hypertension, post-traumatic brain syndrome etc.
  • Participants who have taken migraine prophylactic medication regularly during 1 month prior to Screening stage.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

The People's Hospital,Huaibei

Huaibei, Anhui, 235000, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Daxing hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, 102600, China

Location

Quanzhou First Hospita

Quanzhou, Fujian, 362002, China

Location

SanMing First Hospital

Sanming, Fujian, 365000, China

Location

The People's Hospital,Cangzhou

Cangzhou, Hebei, 061000, China

Location

Langfang hospital of Traditional Chinese Medicine

Langfang, Hebei, 065000, China

Location

The two six zero hospital of Chinese people's Liberation Army

Shijiazhuang, Hebei, 050000, China

Location

Tangshan TCM Hospital

Tangshan, Hebei, 063000, China

Location

Kaifeng hospital of Traditional Chinese Medicine

Kaifeng, Henan, 475000, China

Location

Luohe hospital of Traditional Chinese Medicine

Luohe, Henan, 462000, China

Location

Wuhan sixth hospital

Wuhan, Hubei, 430000, China

Location

Yiyang central hospital

Yiyang, Hunan, 413000, China

Location

The Affiliated Hospital of Changchun University of Chinese medicine

Changchun, Jilin, 130117, China

Location

Jilin brain hospital

Siping, Jilin, 136000, China

Location

Jinan hospital of traditional Chinese Medicine

Jinan, Shandong, 250000, China

Location

The second affiliated hospital of Shandong Traditional Chinese Medicine University

Jinan, Shandong, 250000, China

Location

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272000, China

Location

Jining First Hospital

Jining, Shandong, 272000, China

Location

Xi An Hospital of Traditional Chinese Medicine

Xian, Shanxi, 710021, China

Location

Related Publications (1)

  • Yu S, Ran Y, Xiao W, Tang W, Zhao J, Chen W, Zhuang H, Ouyang C, Lin H, Liu D, Chen T, Huang H, Wang B, Hao Y, Yan Z, Zhao S, Wang Y, Ni J, Wang C, Ding W, Li G, Cao J, Tian S. Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial. BMC Complement Altern Med. 2019 Dec 16;19(1):370. doi: 10.1186/s12906-019-2775-2.

    PMID: 31842860DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sugars

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Shengyuan Yu

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2015

Study Completion

November 1, 2015

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

CN(20)