A Randomized, Placebo-Controlled, Double-blind Study of T... | NCT02035111

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jan 10, 2014

First Submission Date that Met QC Criteria

Jan 10, 2014

First Posted Date

Jan 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2016

Last Update Posted Date

Apr 15, 2016Estimated

Name	Class
Beijing Bionovo Medicine Development Co., Ltd.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Primary headache disorders,particularly migraine is globally prevalent. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs.

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache. To provide a safe and effective treatment of Migraine Headache.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

947Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tianshu capsule	Drug		Tianshu capsule
Sugar pill

Measure	Description	Time Frame
Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline		-4w,0,4w,8w,12w,16w

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Participants who are taking part in other clinical trials.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Shengyuan Yu	Chinese PLA General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The People's Hospital,Huaibei		Huaibei	Anhui	235000	China
Chinese PLA General Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31842860	Derived	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.

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases