Clinical study on the treatment of lumbar intervertebral disc herniation by Hai Tong Pi Formula Cataplasms

Early Phase 1

Recruiting

• Conditions: umbar disc herniation

• Registration Number: ITMCTR2024000077
• Lead Sponsor: Wangjing Hospital of China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

(1) Meet the diagnostic criteria for lumbar disc herniation in Chinese and Western medicine;
(2) Chinese citizens between the ages of 40 and 60;
(3) Be in good mental condition and be able to sign the relevant informed consent form;
(4) Not undergoing any treatment related to this disease for at least 14 days before entering the study and not participating in other ongoing studies.
(5) Volunteer for the study and be enrolled in the study;
(5) Volunteer to be tested and sign the informed consent form by themselves, and the process of informed consent is in accordance with the Good Clinical Practice (GCP) for quality management of drug clinical trials.
(5) Voluntarily undergo the trial and sign the informed consent form by themselves, and the process of informed consent is in accordance with the Good Clinical Practice (GCP) of the drug clinical trial;
(6) Reside in the place where they receive treatment, which is conducive to treatment and follow-up;

Exclusion Criteria

(1) Combination of other diseases with medication that affects the results of the test;
(2) Those who have previous spinal infections, traumatic fractures, tumors, tuberculosis, severe fracture laxity, ankylosing spondylitis and other diseases that affect the test results.
(2) Those with previous spinal infections, trauma fractures, tumors, tuberculosis, severe fracture laxity, ankylosing spondylitis and other diseases that affect the test results
(3) Those with contraindications to manipulation, such as severe heart, brain, lung, kidney and other organic diseases and pregnant and lactating women.
(3) Those with contraindications to manipulation, such as severe heart, brain, lung, kidney and other organic diseases and pregnant and lactating women;
(4) Contraindications to the use of topical medications, such as local skin damage, wounds;
(5) In the acute stage of the disease, pain score VAS scale > 7 points;
(6) People with infectious diseases, infectious diseases and bleeding tendency, as well as people who cannot complete the evaluation follow-up due to cognitive impairment.
(6) Those with infectious diseases, infectious diseases, bleeding tendency, and those who are unable to complete the evaluation follow-up due to cognitive impairment;
(7) Those who are allergic to drugs or have had serious drug allergic events in the past;
(8) Those who are undergoing other clinical trials at the same time and those who refuse to sign the informed consent;

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oswestry disability index;Visual analogue scales,VAS;Chinese Medicine Symptom Rating Scale;surface electromyography;

Secondary Outcome Measures

Name	Time	Method
Quantitative checklist of typical signs;Lumbar pressure pain test;lumbar spine mobility;