Efficacy and Safety of Ushaq Capsule as Adjunctive Therapy in Patients With Lumbar Radiculopathy: A Double‐Blind, Randomized, Placebo‐Controlled Clinical Trial at Imam Khomeini Hospital, Tehran, Iran

BACKGROUND: Sciatica and lumbar radicular pain are prevalent symptoms affecting a large proportion of people worldwide. Many patients seek complementary and alternative medicine for pain relief. This study aimed to evaluate the efficacy and safety of Ushaq capsule, a herbal formulation from Traditional Persian Medicine, on pain intensity and disability in patients with lumbar radiculopathy. METHODS: This randomized, double-blind, placebo-controlled clinical trial included 68 patients randomly assigned to intervention or placebo groups. All participants were allowed to use diclofenac 50 mg (up to three tablets daily) as rescue medication for breakthrough pain. Participants in the intervention group received 3 Ushaq capsules daily for 6 weeks, while the placebo group received identical microcrystalline cellulose capsules. Pain intensity and disability were assessed using the Visual Analogue Scale (VAS) and Roland Morris Disability Questionnaire (RMDQ). The primary endpoint was the change in VAS score from baseline to week 6. Safety was evaluated through clinical adverse event monitoring and laboratory tests. RESULTS: No significant baseline differences were observed between the groups (p > 0.05). The mean VAS score was significantly lower in the Ushaq group from the second week onward (p = 0.019) and remained significant until the end of the study (p = 0.003). The RMDQ score decreased significantly in both groups, but the reduction in the Ushaq group was not significantly greater than that in the placebo group (p = 0.218). No serious adverse events were reported; only mild, transient gastrointestinal discomfort occurred (Ushaq: 6.5%, placebo: 4.3%). CONCLUSIONS: Ushaq capsules as adjunctive therapy with diclofenac as rescue medication showed greater pain reduction compared to placebo with a favourable safety profile. Larger, longer-term trials with active comparators are needed to confirm these preliminary findings. TRAIL REGISTRATION: The research was registered with the Iranian Registry of Clinical Trials (IRCT) and received registration number IRCT20200418047124N1.