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A randomized, double-blind, parallel controlled, multicenter clinical trial evaluating the safety and effectiveness of Sanpian Decoction in the treatment of migraine

Clinical application of Sanpian decoction on migraine and related effect mechanism research

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074479
Enrollment
Unknown
Registered
2023-08-08
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

migraine

Interventions

Chinese medicine group:Sanpian Decoction Granules + Sibeline Simulator
Western medicine group:Sibiling Capsules + Sanpian Decoction Granule Simulator
Placement control group: Sanpian Decoction Granule Simulator + Sibeline Capsule Simulator

Sponsors

Henan Provincial Hospital of Traditional Chinese Medicine (The Second Affiliated Hospital of Henan University of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Comply with ICHD-3 unprepared signs and aura migraine diagnosis standards; (2) Compliance with Chinese medicine head wind disease and/or phlegm syndrome, and/or depression, and/or blood stasis diagnosis standards; (3) Age 18-65 years old; (4) The age of the first migraine attack is =50 years; the course of disease is = 1 year; (5) In the past 3 months, the number of headaches every 4 weeks is 2 to 8 times (including 2 and 8 times); (6) Drugs that have not taken migraine for the past 1 month, such as calcium ionic channel blockers, ß -blockers, antidepressants and antiepileptic drugs, etc.; (7) Those who have no abnormalities in the conventional physical examination of the group; (8) Those who can complete the headache diary and sign the consent of informed consent as required.

Exclusion criteria

Exclusion criteria: (1) Those who have headaches caused by the history of head trauma, nervous headache, cluster headache or other organic diseases; (2) Those with long -term analgesic drugs, as well as abuse of alcohol or other drugs; (3) Those who combine liver, kidney, digestion, hematopoietic, cardiovascular system and other serious primary diseases; (4) Participate in other clinical trials at the same time; (5) Women during pregnancy or lactation, or those who are planning to be pregnant within 6 months. (6) Allergic to drugs and its auxiliary materials involved in this study.

Design outcomes

Primary

MeasureTime frame
headache diary;

Secondary

MeasureTime frame
Headache Score;TCM Syndrome Points;MSQ;HIT-6;GAD-7;Serum CGRP, 5-HT, PACAP-38, ROS?SOD?TAS?TOS?4-HNE?MDA;IL-1ß?IL-6?IL10?TNF-a;safety outcome;PHQ-9;

Countries

China

Contacts

Public ContactYinglin Cui

Henan Provincial Hospital of Traditional Chinese Medicine (The Second Affiliated Hospital of Henan University of Chinese Medicine)

cylu52190@163.com+86 150 3805 8083

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026