A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.

To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.

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

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Sugar pill; Drug: Tianshu capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 947
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Huaibei, Anhui, China, 235000
      • The People's Hospital,Huaibei
  • Beijing
    • Beijing, Beijing, China, 100039
      • Chinese PLA General hospital
    • Beijing, Beijing, China, 102600
      • Daxing hospital of Traditional Chinese Medicine
  • Fujian
    • Quanzhou, Fujian, China, 362002
      • Quanzhou First Hospita
    • Sanming, Fujian, China, 365000
      • Sanming First Hospital
  • Hebei
    • Cangzhou, Hebei, China, 061000
      • The People's Hospital,Cangzhou
    • Langfang, Hebei, China, 065000
      • Langfang hospital of Traditional Chinese Medicine
    • Shijiazhuang, Hebei, China, 050000
      • The two six zero hospital of Chinese people's Liberation Army
    • Tangshan, Hebei, China, 063000
      • Tangshan TCM Hospital
  • Henan
    • Kaifeng, Henan, China, 475000
      • Kaifeng Hospital of Traditional Chinese Medicine
    • Luohe, Henan, China, 462000
      • Luohe Hospital of traditional Chinese Medicine
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Wuhan Sixth Hospital
  • Hunan
    • Yiyang, Hunan, China, 413000
      • Yiyang Central Hospital
  • Jilin
    • Changchun, Jilin, China, 130117
      • The Affiliated Hospital of Changchun University of Chinese medicine
    • Siping, Jilin, China, 136000
      • Jilin brain hospital
  • Shandong
    • Jinan, Shandong, China, 250000
      • Jinan hospital of traditional Chinese Medicine
    • Jinan, Shandong, China, 250000
      • The second affiliated hospital of Shandong Traditional Chinese Medicine University
    • Jining, Shandong, China, 272000
      • Affiliated hospital of Jining Medical University
    • Jining, Shandong, China, 272000
      • Jining First Hospital
  • Shanxi
    • Xian, Shanxi, China, 710021
      • Xi An Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tianshu capsule; Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks.	Drug: Tianshu capsule
Placebo Comparator: Sugar pill; Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks.	Drug: Sugar pill

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
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
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, and clinical laboratory tests.	Adverse event reports will be assessed at 0, 4w, 8w, 12w, 16w. clinical laboratory tests including WBC, RBC, HGB, PLT, LEU, ERY, PRO,Stool routine, ALT, AST, TBil, ALP, GGT, BUN, Cr will be assessed at 0, 12w. Electrocardiogram will be assessed at 0, 12w. Vital sign measurements will be assessed at -4w, 0, 4w, 8w, 12w, 16w.	0, 12w

Collaborators and Investigators

• Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
• Collaborators: Beijing Bionovo Medicine Development Co., Ltd.
• Investigators: Principal Investigator: Shengyuan Yu, Chinese PLA General hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Migraine; Tianshu capsule
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: Z-TSJN-JN-Ⅳ