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Table 2 Proposed elaborations of CONSORT items for randomized, controlled trials of FFDS tablets interventions

From: The efficacy and safety of Fufangdanshen tablets (Radix Salviae miltiorrhizae formula tablets) for mild to moderate vascular dementia: a study protocol for a randomized controlled trial

Paper section and topic

Item number

Descriptor

Reported on page number

Title and Abstract

1

How participants were allocated to interventions (e.g., “random allocation,” “randomized,” or “randomly assigned”)

1,3

Either the title or abstract, or both, should state the herbal medicinal product’s Latin binomial, the part of the plant used, and the type of preparation

Introduction

Background

2

Scientific background and explanation of rationale

4,5

Including a brief statement of reasons for the trial with reference to the specific herbal medicinal product being tested and, if applicable, whether new or traditional indications are being investigated

Methods

Participants

3

Eligibility criteria for participants and the settings and locations where the data were collected

5,6

If a traditional indication is being tested, a description of how the traditional theories and concepts were maintained. For example, participant inclusion criteria should reflect the theories and concepts underlying the traditional indication

Interventions

4

Precise details of the interventions intended for each group and how and when they were actually administered

 
 

4A: Herbal medicinal product name

1. The Latin binomial name and the botanical authority and family name for each herbal ingredient; common name(s) should also be included

6

2. The proprietary product name (i.e., brand name) or the extract name (e.g., EGb-761) and the name of the manufacturer of the product

3. Whether the product used is authorized (licensed, registered) in the country in which the study was conducted

 

4B: Characteristics of the herbal product

1. The part(s) of plant used to produce the product or extract

 

2. The type of product used (e.g., raw [fresh or dry], extract)

3. The type and concentration of extraction solvent used (e.g., 80 % ethanol, 100 % H2O, 90 % glycerin, etc.) and the ratio of herbal drug to extract (e.g., 2 to 1)

4. The method of authentication of raw material (i.e., how done and by whom) and the lot number of the raw material. State if a voucher specimen (i.e., retention sample) was retained and, if so, where it is kept or deposited, and the reference number

 

4C: Dosage regimen and quantitative description

1. The dosage of the product, the duration of administration, and how these were determined

6,7

2. The content (e.g., as weight, concentration; may be given as range where appropriate) of all quantified herbal product constituents, both native and added, per dosage unit form. Added materials, such as binders, fillers, and other excipients (e.g., 17 % maltodextrin, 3 % silicon dioxide per capsule), should also be listed)

3. For standardized products, the quantity of active/marker constituents per dosage unit form

 

4D: Qualitative testing

1. Product’s chemical fingerprint and methods used (equipment and chemical reference standards) and who performed the chemical analysis (e.g., the name of the laboratory used). Whether a sample of the product (i.e., retention sample) was retained and if so, where it is kept or deposited

No

2. Description of any special testing/purity testing (e.g., heavy metal or other contaminant testing) undertaken; which unwanted components were removed and how (methods)

3. Standardization: what to standardize (e.g., which chemical components of the product) and how (e.g., chemical processes, or biological/functional measures of activity)

 

4E: Placebo/control group

The rationale for the type of control or placebo used

6,7

 

4 F: Practitioner

A description of the practitioners (e.g., training and practice experience) who are a part of the intervention

8

Objectives

5

Specific objectives and hypotheses

 

Outcomes

6

Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors)

8,9

Outcome measures should reflect the intervention and indications tested considering, where applicable, underlying theories and concepts

Sample size

7

How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules

7

Randomization Sequence allocation

8

Method used to generate the random allocation sequence, including details of any restriction (e.g., blocking, stratification)

7

Allocation concealment

9

Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned

7

Implementation

10

Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups

7

Blinding (masking)

11

Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated

7

Statistical methods

12

Statistical methods used to compare groups for primary outcome(s); methods for additional analyses, such as subgroup analyses and adjusted analyses

10