Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2023-03-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acupuncture
Hwato brand disposable acupuncture needles (size 0.30 × 40 mm) and adhesive pads will be used. Acupoints of Guanyuan, Zhongwan, Tianshu, Zusanli, Taixi, Shangyintang, Taiyang, Hegu, Taichong and Shenmen will be selected. Participants will receive a total of 10-session acupuncture treatment during four weeks, three times a week in the first two weeks and twice a week in the last two weeks.
Acupuncture
For Shangyitang acupoint, the needle will be inserted towards the direction of nasal tip horizontally to a depth of 10-20mm without any manipulation, and a pad will be adhered afterwards. For other acupoints, the needles will be inserted through adhesive pads to 10-20mm. Needles will be lifted, thrust, and twirled for 3 times to achieve deqi sensation, and will be manipulated every ten minutes during 30-minute maintenance.
Sham Acupuncture
Hwato brand disposable placebo needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) and adhesive pads will be used. Acupoints of Guanyuan, Zhongwan, Tianshu, Zusanli, Taixi, Shangyintang, Taiyang, Hegu, Taichong and Shenmen will be selected. Participants will receive a total of 10-session sham acupuncture treatment during four weeks, three times a week in the first two weeks and twice a week in the last two weeks.
Sham Acupuncture
For all the points, the needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrust and twirled for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance.
Interventions
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Acupuncture
For Shangyitang acupoint, the needle will be inserted towards the direction of nasal tip horizontally to a depth of 10-20mm without any manipulation, and a pad will be adhered afterwards. For other acupoints, the needles will be inserted through adhesive pads to 10-20mm. Needles will be lifted, thrust, and twirled for 3 times to achieve deqi sensation, and will be manipulated every ten minutes during 30-minute maintenance.
Sham Acupuncture
For all the points, the needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrust and twirled for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance.
Eligibility Criteria
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Inclusion Criteria
* Confirmed COVID-19 infection in the past four weeks to six months, and a negative RT PCR and/or Antigen-Based Rapid Test at present.
* A main complaint of fatigue emerged newly following COVID-19 infection.
* A score of ≥15 on Chalder Fatigue Scale (CFS, score range 0-33).
* Participating the trial volunteerly and providing written informed consent.
Exclusion Criteria
* Significant cognitive dysfunction or suicidal tendency.
* Usage of anti-anxiety and/or anti-depression treatments over the last three months.
* Previously diagnosed hypothyroidism or chronic fatigue syndrome.
* A complication of serious and poorly controlled underlying diseases.
* Having symptoms indicating emergency or severe conditions.
* Concurrent use of other anti-fatigue agents or treatments at present.
* Impaired walking ability.
* Pregnant and/or lactating or planning to get pregnant in the next 4 months.
18 Years
75 Years
ALL
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Yuanjie Sun
Principal Investigator
Central Contacts
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Other Identifiers
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2023-013-KY-01
Identifier Type: -
Identifier Source: org_study_id
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