Pharmacognostical, Analytical Evaluation and Clinical Efficacy of Nirgundi (Vitex negundo Linn.) leaves (water soluble Extract) in the Management of Sthaulya : A Randomized Placebo-Controlled

The present study is a prospective, interventional clinical study designed to scientifically evaluate the safety and clinical efficacy of the water-soluble extract of Nirgundi (Vitex negundo Linn.) leaves in human participants. The study will be conducted at a single study center after obtaining approval from the Institutional Ethics Committee and will be registered with the Clinical Trials Registry of India (CTRI).

MethodologyEligible participants fulfilling the predefined inclusion and exclusion criteria will be enrolled after obtaining written informed consent. The investigational drug, i.e., water-soluble extract of Nirgundi leaves, will be prepared and standardized as per classical Ayurvedic principles and relevant pharmacognostical and analytical guidelines.

Baseline assessment will include detailed clinical evaluation and necessary laboratory investigations to establish safety parameters. Participants will receive the study intervention for a fixed treatment duration as mentioned in the protocol and will be followed up at scheduled intervals for assessment of therapeutic response and safety.

Study GroupsParticipants will be allocated into the following groups as per the approved protocol

• Study Group: Participants receiving the water-soluble extract of Nirgundi leaves in the prescribed dose and duration.
• Control/Comparator Group : Participants receiving standard care/placebo/controlled intervention as defined in the protocol.

Outcome MeasuresThe primary outcome will focus on assessment of safety, evaluated through clinical examination and laboratory parameters. Secondary outcomes will include assessment of clinical efficacy parameters relevant to the disease condition under study. All participants will be closely monitored for any adverse events throughout the study period.

Ethical ConsiderationsThe study will be conducted in accordance with Good Clinical Practice (GCP) guidelines and ethical principles. Confidentiality of participant data will be maintained, and participants will have the right to withdraw from the study at any time.

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