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IRCT20250605066071N1 IRCT 2025-08-14 Boushehr University of Medical Sciences Effectiveness of Pardihan Syrup in Managing Mild to Moderate Postpartum Depression Preliminary Evaluation of the Efficacy of Pardihan Syrup (a Combination of Grape Syrup, Apple Extract, and Basil) in Managing Postpartum Depression (PPD): A Pilot Study 2025-07-16 anticipated 20 Complete https://irct.ir/trial/84248 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization will be used to allocate participants into groups. Given the small sample size of the study (20 participants), this method ensures that the number of participants remains balanced between the intervention and control groups at each stage of sampling. The allocation process is as follows: 1. Blocks of four participants (with six possible combinations such as AABB, ABAB, ABBA, BBAA, BABA, BAAB) will be generated by a third party who is not involved in the screening or enrollment of participants. 2. The allocation sequence based on the randomized blocks will be placed in sealed and numbered envelopes (allocation concealment). 3. After obtaining informed consent from each eligible participant, the envelopes will be opened in numerical order, and the participant will be assigned to the designated group (A: intervention or B: placebo), Blinding description: This study is designed as a double-blind trial, meaning that participants, the treatment/research team, and outcome assessors are all unaware of the type of intervention each group receives. To ensure successful blinding, the pharmaceutical company Sanabel Darou has manufactured the placebo to be indistinguishable from the active syrup in all visible characteristics, including color, taste, smell, viscosity, and packaging. Bottles for both groups are labeled with a unique code, and only the allocation officer (the third party) is aware of the actual contents. The codes will remain undisclosed until the completion of the statistical analysis. N/A Postpartum depression, Anxiety. Intervention 1: The intervention group will receive Pardehan syrup at a dose of 10 cc (equivalent to one tablespoon), three times a day for 30 consecutive days. Intervention 2: The control group will receive the placebo syrup at the same dose of 10 cc (equivalent to one tablespoon), three times a day for 30 consecutive days. Yes - There is a plan to make this available What will be shared: The shared materials will include the de-identified Individual Participant Data (IPD), the final Study Protocol, the Statistical Analysis Plan (SAP), and the corresponding Data Dictionary. The IPD dataset will encompass all variables collected for the primary and secondary outcomes, including but not limited to: baseline demographic characteristics, complete scores from the PHQ-9 questionnaire, quality of life and sleep assessments, and baseline hematological parameters. The Data Dictionary will be provided to ensure the full interpretability of the dataset by defining each variable, its unit of measurement, and coding scheme. All data will be fully anonymized to protect participant confidentiality. When: Access to the data and related documents will become available starting 1 year after the publication of the primary study results. This access will be guaranteed for a minimum period of 1 year from the start date to support scientific verification and secondary research. To whom: Access will be granted to qualified researchers affiliated with accredited academic, scientific, or non-commercial research institutions for the purpose of conducting verifiable scientific inquiry. Conditions: The data or documentation provided is intended solely for legitimate research purposes. Use of this data must align with clearly defined scientific objectives, a sound research design, and adherence to ethical research principles. Applicants must be affiliated with an academic or research institution and are required to commit to using the data exclusively for the purpose stated in their request. Requesters must also provide assurance of their capacity to store the data securely in accordance with their institutional data protection policies. Sharing the data with third parties without prior written permission is strictly prohibited. Use of the data for commercial or promotional activities is strictly prohibited, unless explicitly authorized by the Principal Investigator of the original study. Any request for such use will be subject to a rigorous review based on the scientific, ethical, and public health merits of the proposal. Approval is granted solely at the discretion of the Principal Investigator, and if granted, will be governed by a separate, legally binding agreement that specifies the precise terms and conditions of use. In the event that the data is used in published articles or reports, appropriate citation of the data source is mandatory, and collaboration with the original research team must be acknowledged. Where to obtain: Requests should be directed via email to the corresponding author (M.j.mousavi@bpums.ac.ir). Should this contact be unavailable, inquiries can be directed to the research office of Bushehr University of Medical Sciences. How to obtain: To request access to the data and associated documents, applicants must submit a formal request via email to the corresponding author. The request must include: 1. A concise research proposal (1-2 pages) detailing the scientific objectives, methodology, and the intended use of the data. 2. The applicant's institutional affiliation and contact information. 3. A signed statement confirming commitment to data confidentiality and secure storage. The Principal Investigator (PI) and research team reserve the right to request additional information or clarification regarding the proposal. All complete applications will be reviewed by the PI and research team. The review will assess the scientific merit, ethical soundness, and feasibility of the proposed research, ensuring it does not conflict with ongoing or planned analyses by the original team. The PI reserves the full right to approve or reject any request based on this review. The review process is expected to take 2 to 4 weeks, commencing from the date a complete application is received. The decision of the review team is final. If the request is approved, the applicant will be required to sign a formal Data Sharing Agreement (DSA) before access is granted. Following the execution of the DSA, data will be provided in a de-identified format and in a standard, non-proprietary file type (e.g., CSV). Comments:
public Seyed Mohammad Javad Mousavi
Student Research Committee, Bushehr University of Medical Sciences, Bushehr, Rishehr St., Salman Farsi St., Pardis Complex
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3345 0178 M.j.mousavi@bpums.ac.ir Boushehr University of Medical Sciences scientific Seyed Mohammad Javad Mousavi
Student Research Committee, Bushehr University of Medical Sciences, Bushehr, Rishehr St., Salman Farsi St., Pardis Complex
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3345 0178 M.j.mousavi@bpums.ac.ir Boushehr University of Medical Sciences Iran (Islamic Republic of) 1.Mothers with mild to moderate postpartum depression. 2.Mothers aged between 18 and 40 years, who are 2 to 12 weeks postpartum. 3. 4. 5. 6. Mothers aged between 18 and 40 years, who are 2 to 12 weeks postpartum. No use of antidepressant medications to manage the condition. Birth of a healthy infant.Mothers must have at least basic literacy (reading and writing skills). Pregnancy must have been low-risk. Maternal body mass index (BMI) must be less than or equal to 40 kg/m². 18 years 40 years Female Mother's unwillingness to continue participating in the study to receive syrup for 2 consecutive days Sensitivity to Pardihan syrup A history of previous depression with an unrelated cause A history of taking antidepressants Women who suffer from other mental illnesses or take related medications having Diabetes having Polycystic ovary syndrome Failure to complete the course of taking interventions F53.0 Postpartum depression, Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified Treatment - Other Placebo The intervention group will receive Pardehan syrup at a dose of 10 cc (equivalent to one tablespoon), three times a day for 30 consecutive days. The control group will receive the placebo syrup at the same dose of 10 cc (equivalent to one tablespoon), three times a day for 30 consecutive days. Depression score. Timepoint: Filling out the questionnaire will be done at the beginning of the study (before the intervention) and 30 days after the start of the study. Method of measurement: Physical Health Questionnaire (PHQ). Sleep quality. Timepoint: Filling out the questionnaire will be done at the beginning of the study (before the intervention) and 30 days after the start of the study. Method of measurement: Pittsburgh Sleep Quality Index. Intensity of anxiety. Timepoint: Filling out the questionnaire will be done at the beginning of the study (before the intervention) and 30 days after the start of the study. Method of measurement: Beck Anxiety Inventory. Mother-infant relationship quality. Timepoint: Filling out the questionnaire will be done at the beginning of the study (before the intervention) and 30 days after the start of the study. Method of measurement: Parent-ChildBonding Instrument. Boushehr University of Medical Sciences Approved 2025-04-16 Ethics Committee of Bushehr University of Medical Sciences Student Research Committee, Bushehr University of Medical Sciences, Bushehr, Rishehr St., Salman Farsi St., Pardis Complex Bushehr Boushehr Iran (Islamic Republic of)