Administrative information
Title {1} | The efficacy and safety of Longmu Tang granule for the treatment of atopic dermatitis: study protocol for a single-centred, double-blinded, randomised, placebo-controlled trial |
Trial registration {2a and 2b}. | Chictr.org ID: ChiCTR2100041591. Registered on 1 January 2021. |
Protocol version {3} | 14, May 2020, version 3.2 |
Funding {4} | This work is supported by Chinese Capital’s Funds for Health Improvement and Research (number: 2020-2-4172) |
Author details {5a} | Department of Dermatology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China |
Name and contact information for the trial sponsor {5b} | Contact number: 8610-88549772 |
Role of sponsor {5c} | Capital’s Funds for Health Improvement and Research will provide the funding for this trial and supervise its progress |
Introduction
Background and rationale {6a}
Chinese name | Latin name | English name |
---|---|---|
Long Gu | Os Draconis | Fossilizid |
Calcined Mu Li | Concha Ostreae | Calcined concha ostreae |
Lian Qiao | Forsythia suspensa | Fructus forsythiae |
Toasted Shen Qu | Massa Medicata Fermentata | Toasted medicated leaven |
Fu Ling Pi | Poria cocos | Tuckahoe peel |
Ma Huang Gen | Radixet Rhizonma Ephedrae | Radix ephedrae |
Objectives {7}
Aims
Hypothesis
Objectives
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Diagnostic criteria
Inclusion criteria
Exclusion criteria
Drop out criteria
Public and patient involvement
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
Secondary outcomes
-
Significantly effective: inhibition or complete suppression of primary and secondary clinical symptoms and reduction of the syndrome score by ≥ 95%
-
Effective: significant improvement in clinical symptoms and reduction in the syndrome score by 70–95%
-
Ineffective: improvement in clinical symptoms and reduction in the syndrome score by 50–70%
-
Invalid: reduction of treatment syndrome score by < 50%
None | Mild | Moderate | Severe | ||||
---|---|---|---|---|---|---|---|
Primary symptoms | |||||||
Itch | 0 | 2 | 4 | 6 | |||
Patterns of skin lesion | 0 | 2 | 4 | 6 | |||
Area of skin lesion | 0 | < 10% | 10–29% | 30–49% | 50–69% | 70–89% | 90–100% |
0 | 1 | 2 | 3 | 4 | 5 | 6 | |
Secondary symptoms | |||||||
Restlessness | 0 | 1 | 2 | 3 | |||
Dry mouth | 0 | 1 | 2 | 3 | |||
Sleeplessness | 0 | 1 | 2 | 3 | |||
Dry stool | 0 | 1 | 2 | 3 | |||
Scanty dark urine | 0 | 1 | 2 | 3 |
None | Mild | Moderate | Severe | |
---|---|---|---|---|
Itch | No symptom | Occasional occurrence and no influence on study and life | Regular occurrence and have influence on study and life | Frequent occurrence and have serious influence on study and life |
Patterns of skin lesion | No symptom | Erythema, papules, or blisters | Oozing | Skin thickening (lichenification) |
Area of skin lesion | Calculated based on PASI score | |||
Restlessness | No symptom | Slight | Heavy | Heavy; irritable |
Dry mouth | No symptom | Slight; no need to drink water | Severe; need to drink water occasionally | Intolerable; need to drink water frequently |
Sleeplessness | No symptom | Slower falling asleep or occasional waking | Difficult to fall asleep and wake up easily | Hardly able to sleep |
Dry stool | No symptom | Dry stool; once per day | Dry stool, 1 time in 2–3 days | Difficult stool, > 3 days each time |
Scanty dark urine | No symptom | Urine volume is fine, slightly yellowish in colour | Small amount of urine, yellow colour, slightly hot | Scanty dark urine |