Clinical study on the efficacy evaluation of traditional Chinese medicine auricular point acupressure in alleviating pain, fatigue and gastrointestinal adverse reactions after injection of novel coronavirus-19 vaccines

Not Applicable

Recruiting

• Conditions: pain, fatigue and gastrointestinal adverse reactions after injection of novel coronavirus-19 vaccines

• Registration Number: ITMCTR2100004879
• Lead Sponsor: Hospital of Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Vaccinators meets the conditions of coronavirus-19 vaccines injection and has no contraindications to it. The details shall be subject to the instructions of the coronavirus-19 vaccines used and the statement of medical institutions. The first dose of coronavirus-19 vaccines injection shall be completed within 24 hours from the time of injection to the time of enrollment;
2. No redness, swelling, injury or infection of the skin or soft tissue of both ears, which is not suitable for auricular points plasters sticking;
3. No history of alcohol and adhesive tape contact allergy;
4. Aged 18-59 years old;
5. Those who were able to complete the questionnaire independently at the time of the first and second dose of vaccine and on the 3rd, 7th and 15th day after the first and second dose of vaccine respectively;
6. Those who agree to participate in the trial and sign the informed consent, and can seriously abide by the precautions after the injection of coronavirus-19 vaccines and the requirements of traditional Chinese medicine auricular point plasters sticking and acupressure.

Exclusion Criteria

1. Those who are not suitable to be vaccinated because they belong to the contraindication or cautious population;
2. Those who have participated in other clinical trials within 4 weeks before the start of this study;
3. Headache occurred more than 3 times in the past week, and the degree of pain affected daily life; Or the subjects reported the following headache diseases: such as primary headache (migraine, tension headache, cervicogenic headache), and other diseases leading to secondary headache; Or the subjects had a long-term history of chronic headache (> 3 months), but the diagnosis was not clear or the cause was unknown;
4. Muscle or joint pain in other parts of the body occurred more than 3 times in the past week, and the degree of pain had an impact on daily life; Or the subjects reported the existing muscle or joint pain diseases, such as periarthritis of shoulder, tendinitis, rotator cuff injury, tenosynovitis, tenosynovitis, muscle or joint injury, rheumatoid arthritis or rheumatoid arthritis pain, and muscle with pain; Or the patients had a long history of chronic muscle or joint pain (> 3 months), but the diagnosis was not clear or the cause was unknown;
5. There were more than 3 times of unexplained obvious fatigue in the past week, and the degree of fatigue had an impact on daily life; Or the subjects reported the following fatigue related diseases: malignant tumor (cancer), hypotension, chronic fatigue syndrome, anemia, pulmonary heart disease, chronic obstructive pulmonary disease, cold, hypothyroidism, hypoglycemia, heart failure, diabetes, etc.; Or subjects with a long-term history of fatigue (> 3 months), but no clear diagnosis or unknown cause;
6. There were more than 3 times of unexplained diarrhea in the past week, which affected daily life; Or the subjects reported the following diarrhea related diseases: enteritis, hyperthyroidism, diabetes, gastrointestinal cancer, Crohn's disease, intestinal tuberculosis, intestinal fungal infection, chronic bacillary dysentery, etc.; Or the subjects had a long history of diarrhea (> 3 weeks), but the diagnosis was not clear or the cause was unknown;
7. Nausea, retching or vomiting of unknown cause occurred for more than 4 times in the past week, which affected daily life; Or the subjects reported the following nausea, retching or vomiting related diseases: such as Meniere's syndrome, vestibular neuritis, gastritis, enteritis, gastroesophageal reflux disease, intestinal obstruction, intussusception, motion sickness, hyperthyroidism, gastrointestinal cancer, etc.; Or the subjects had Long term history of nausea, retching or vomiting (> 1 month), but no definite diagnosis or unknown cause;
8. Those who are in use or have received traditional Chinese medicine auricular point plasters sticking and acupressure within 2 weeks before the trial;
9. Pregnant or lactating women;
10. Patients with other serious primary diseases and psychosis.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
VAS score of headache;VAS score of nausea;VAS score of fatigue;VAS score of muscle and joint pain;VAS score of vomitting;VAS score of retching;VAS score of pain at injection site;VAS score of diarrhea;