CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Standard Treatment +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04392141
NCT04392141Phase 2Completed

Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19

Kermanshah University of Medical Sciences·interventional·Posted May 18, 2020·Updated Apr 20, 2021

In Brief

A Phase 2 clinical trial evaluating Standard Treatment and Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions for COVID-19. Completed, enrolled 120 participants across 1 site.

Detailed Summary

In this randomized controlled clinical trial, defined cases of COVID-19 with mild, moderate, or severe pneumonia (according to the NIH guideline) were treated with conventional treatment regimens (controls) as well as in combination with oral administration of colchicine plus herbal phenolic monoterpene fractions (intervention arm). After randomization, each group received the mentioned treatments and were evaluated for different variables including mortality, hospitalization duration, intensive care unit (ICU) administration ratios as well as laboratory variables such as leukocytes and lymphocytes count. The follow-up period considered as 2 weeks after discharge. The mentioned variables were assessed as before and after receiving the treatment in each group as well as intergroup analysis for comparing both baseline and final values.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesIran
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 18, 2020
Enrollment StartApr 1, 2020
Primary CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.1 years ago

Interventions

Standard Treatmentdrug

Standard Treatment for COVID-19 based on National Recommendations

Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractionsdrug

Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19.