"A controlled trial means that study participants are split into two groups: One group is given the treatment and the other (the control group) is not. The control group may be given a placebo that mimics the actual treatment, but does not contain the treatment being tested.
For example, a sugar pill or an injection of saline solution may be used instead of a dose of the drug. This ensures the only meaningful difference between the two groups is whether they received the treatment or not.
The control group helps researchers learn what would have happened to the treatment group if they hadn’t received the treatment. For example, some patients may recover on their own. Researchers need to know how often this happens, so they don’t attribute all recoveries to the effect of the treatment.
Study participants are randomly assigned to one group or the other, a process similar to a coin toss. Just as a coin toss is equally likely to end up heads or tails, study participants are equally likely to end up in the treatment or the control group. With enough study participants, this results in two groups that closely resemble each other. The only difference is that one group got “heads” while the other got “tails.”
The randomization of randomized-controlled trials with large enough samples ensures that all possible differences are accounted for, even those that may not be observed, such as genetic traits.
If the treatment and control groups are similar at the start of the study but end up with different outcomes, the treatment is the most likely cause. The randomized-controlled trial allows researchers to rule out alternative explanations."
From "What is a clinical trial? A health policy expert explains" in Credo Reference.