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Journal of Research in Ayurvedic Sciences 2019 October - December ; 3 (4) :144-151
Clinical Evaluation of the Efficacy of Saubhagyashunthi Paka and Dashamularishta in Sutika Paricharya (Postnatal Care): Study Protocol for an Open-label, Noncontrolled Trial

Abstract
Background: The postnatal period begins immediately after the separation of the placenta extending up to 6 weeks, otherwise called as the puerperium or puerperal period. The care given during this period is called as Sutika Paricharya (postnatal care) in Ayurveda. During the time of labor, the mother undergoes tremendous physical exertion and becomes extremely debilitated, physically and mentally, which leads to derangement of Dosha especially Vatadosha in the mother. These factors cause general weakness, pain in the abdomen, low back pain, loss of appetite, dysfunction of the bladder, postnatal psychosis, etc. Apart from these, the mother also suffers with Dhatukshaya (weakness of body tissue). Prevention of puerperal sepsis, management of other complications, proper involution of genital organs, and proper lactation need to be well managed during the puerperal period. Based on the information available in the Ayurvedic texts regarding the management during Sutika Kala (postnatal phase), this study has been designed to assess the clinical efficacy of two Ayurvedic classical formulations, viz., Saubhagyashunthi Paka and Dashamularishta for the effective management of the puerperal phase. Materials and methods: A single-center, noncontrolled, open-label clinical trial as a means of assessing the therapeutic efficacy of Saubhagyashunthi Paka and Dashamularishta will be conducted. A total of 40 participants will be recruited for the study. The study period is 12 months, during which all the participants will be given the trial drugs for a duration of 8 weeks along with the standard care as recommended by established guidelines. Outcome measures: The primary outcome measure is to restore the strength of the mother and minimize the complications and establishment of sufficient lactation. The secondary outcomes are improvement in the quality of life and clinical safety of the trial drugs. Statistical evaluation would be done at the end of the trial period to compare the changes in the assessment parameters from the baseline. Discussion: The study will generate the preliminary evidence of the efficacy of Saubhagyashunthi Paka and Dashamularishta in Sutika Paricharya (w.s.r. to postnatal care), which will validate the Ayurvedic therapeutic approach for the management of Sutika Paricharya and will also help to design a randomized controlled trial. Trial registration: Clinical Trials Registry—India [CTRI/2020/01/022935] Keywords: Ayurvedic formulations, Clinical trials, Dashamularishta, Postnatal care, Saubhagyashunthi paka, Sutika paricharya

DHARA ID: D059636


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