Herbal medicine clinical trial software

A herbal trial combines the regulatory complexity of a medicine with the variability of a natural product. The same plant grown in two places can differ in active constituents, a decoction is not the same as a standardised extract, and a traditional formula may be adjusted for each patient. The data capture has to hold the answers to the questions a reviewer will ask: what exactly was given, from which batch, how much was taken and what else was the participant taking.

Where a single standardised extract is tested, the product record is simple: product, batch, dispensed and returned quantities, with the batch certificate (identity and content testing) filed in the study documents. Where the intervention is a multi-herb formula, build a repeating-row table for ingredients with name, form and dose, or a formula code with the composition held in a reference. Modified formulas need a row per prescription change with its date and reason, which the audit trail records. The CONSORT extension for Chinese herbal medicine formulas, published in 2017, lists the product details journals expect to see reported, so design the capture to fill that table; check the current version of the checklist you intend to follow.

For single-ingredient products sold as supplements, see the neighbouring pages on supplement clinical trials and nutraceutical trials. This page is for herbal products and formulas where batch identity, formula composition and herb-drug interactions drive the data. If your formula is delivered through acupuncture visits or traditional diagnosis, see EDC for acupuncture and TCM trials.

Reports of liver injury linked to some herbal products make hepatic monitoring a sensible default for many herbal protocols, though the schedule and thresholds must come from your protocol and a clinician. Build a laboratory form with liver enzymes and bilirubin at the planned visits (the shared lab template and reference-range tables help), add edit checks for plausible values and date order, and a pathway from an abnormal result to an adverse event form with severity, relationship and sign-off. Edit checks raise queries on data entry, they are not clinical alerts, so the protocol must say who reviews results and how fast. See the adverse event template.

Herb-drug interactions need the concomitant medication record to be complete and current. Use a repeating-row table with drug name, dose, start and stop dates and indication, and re-ask at every visit rather than once at baseline. Include over-the-counter products, other herbal remedies and traditional preparations the participant mentions; use free text plus a category so analysis is possible. A participant-facing diary on the phone can prompt for new products between visits.

Adherence for powders, capsules and decoctions is usually counted from returned packs, supplemented by a simple daily diary. Taste and smell make blinding fragile, so ask both the participant and the assessor at the end which product they think was given, and keep the guess separate from the allocation. Capture's blinded roles never receive treatment-arm values, enforced by masked database views and row-level security; randomization can sit in the same study, see randomization in EDC. Primary outcomes are often symptom scores or quality-of-life measures on the participant's phone; where an instrument is copyrighted, the licence stays with the study documents.