Effectiveness of herbal formulations for stress

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: Treatment Arm 1 ‐ Herbal tablet containing: Ziziphus jujuba var. spinosa (Ziziphus), Passiflora incarnata (Passionflower), Melissa officinalis (Lemon balm) and Matricaria chamomilla (Chamomile). Three tablets daily, orally, in divided doses, for 21 days. Treatment Arm 2 ‐ Herbal tablet containing: Withania somnifera (root) and Crocus sativus (stigma). Two tablets daily, orally, in divided doses, for 21 days. Participants in Treatment Arm #1 will be directed to take , one in the morning, one in middle of day, and one in the evening. Participants in Treatment Arm #2 will be directed to take two tablets, orally, daily, one in the morning, and one in the evening. Compliance will be assessed through returned tablet count on completion of study. CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies Mental Health ‐ Anxiety Stress; ; Stress PRIMARY OUTCOME: Change in stress, depression and anxiety indices assessed using the Depression, anxiety, stress scale (DASS‐21). Analysed as a composite outcome (change in overall DASS‐21 score)[Baseline and day 21 after treatment randomisation] SECONDARY OUTCOME: Change in anxiety assessed using Zung Self‐Rating Anxiety Scale (Zung) (assessed in Treatment Arm #1 only)[Baseline and day 21 after treatment randomisation] Change in sleep assessed using PROMIS Sleep Scale ‐ adult short‐form (PROMIS) [Baseline and day 21 after treatment randomisation] Change in stress levels assessed using the Perceived Stress Scale (PSS) [Baseline and day 21 after treatment randomisation] Patient Global Impression of Change[Baseline and day 21 after treatment randomisation] INCLUSION CRITERIA: ‐ ‐ Healthy adults (18‐75 years) ‐ ‐ Any allowable prescription medication use by participants must be stable for four weeks or more prior to trial entry ‐ ‐ Score of 13 or more on the Perceived Stress Scale (PSS‐10)
Epistemonikos ID: 469de69197188297075923f375508d92b8b7f82c
First added on: Feb 20, 2024