Puerperal Care (Sutika Paricharya) Of Women Inhabiting Within Tribal Region Through Ayurvedic Herbal Formulation.

This study is an open labeled, non-randomized, controlled clinical trial for assessment of efficacy and safety of Saubhagya Sunthi Granules in tribal women during puerperium. The sample population is from tribal region of district Dhule, Maharashtra, India. The primary outcome measure will be the effect on involution of uterus, color & amount of lochia and after pains of delivery. The secondary outcome measure will be the effect on lactation and anti-inflammatory effect assessed regularly on Day: 0-3; 10-14; 24-28; 41-45 post natal, as well as Global assessment of safety and efficacy by subjects and investigator at the end of trial.

Due to Lockdown imposed in pandemic of COVID 19, Preperation of investigational product was abandoned. After conditions got better the trial is underway. Trial is open for recruitment since 18/10/2020.

Present clinical trial was planned to reach outsuch deprived population. Control group was the one which practiced theirtraditionally practiced puerperal regimen {sutika paricharya (aahar &vihar)} and experimental group was supplemented with Saubhagya SunthiGranules (SSG) along with traditionally practiced puerperal regimen {sutikaparicharya (aahar & vihar)}. A total 1071 subjects werescreened during Oct 2020 to May 2022. 196 met exclusion criteria, 875 includedto trial by alternate allocation in both groups. The number of subjects droppedout from experimental and control group was 30 & 25 respectively.Completers (400 from either groups) were evaluated statistically on the basisof various demographic as well as subjective and objective parameters. Thequest was to find out effect of consumption of Saubhagya Sunthi Granules(SSG) by puerpera (sutika). The results obtained were discussed incomparison with available previous authentic research conclusions andofficially published records available on internet.

Thelarge sample size was adequate to reach authentic conclusions. The finalconclusions derived are as follows:

•     Consumption of SSG made a brisk and sustained positiveimpact on digestive power of subjects in experimental group whereas in controlgroup the digestive power raised at a gradual physiological rate over a periodof 6 weeks postpartum. This demarcation between both groups is foundstatistically significant.

•     Breast secretions (Lactation) in subjects of experimentalgroup shown more improvement, which is statistically significant.

•     Neonatal weight gain was evaluated more significant inbabies of subjects in experimental group. Thus indicating better quality andquantity of breast milk in subjects of experimental group.

•     Neonatal urine output, stool output and sleep trajectorieswas found better in babies of subjects in experimental group which isconclusive of better amount of breast milk received.

Among laboratory parameters, statisticallysignificant rise in Hemoglobin% was noted in experimental group and reversal ofthe Total Leucocyte Count to normal limits is found more effectively insubjects of experimental group.

•     The subjects in experimental groups has better reversal ofpost-natal obese belly.

•     The subjects in experimental group has a lower rate of postnatal weight retention hence the BMI recorded was also inclined more towardshealthier limits.

•     Observedpercentage of improvement in after pains assessed by VAS scale, is almostidentical for both the groups. Hence SSG is not found much effective in postnatal after pains.

•     There was no statistically significant distinction observedbetween the control and experimental groups concerning the recovery of theperineal wound. But in control group 4 (3.39%) subjects reported with perinealwound dehiscence and another 6 (5.08%) suffered from tender perineal scar.Whereas in experimental group no such adverse event detected.

•     The vital parameters like temperature, pulse and bloodpressure were identical in both groups and mostly noted unaffected.

•     Blood sugar random were found within limits of normal. No significantvariation was observed in both groups.

•     There was no statistically significant distinction observedbetween the control and experimental groups with respect to pattern &amount of lochial discharge and relief from after pains.

Theconclusions are summarized as, major role of Saubhagya Sunthi Granules (SSG)was assumed to aid for involution of genital organs, prevention of post-natalailments and facilitate lactation. All these actions are found affirmative inthe present clinical trial.

Consumptionof SSG duringpuerperal stage has shown excellent effect on digestive power, lactation, enhancedhaemoglobin percentage, reversal of leucocytosis, neonatal weight gain, betterneonatal urine-stool output and better sleep trajectories of neonate.

Moderate efficacy of SSG is seen in reversal ofpost natal obese belly, lower rate of post natal weight retention and healingof perineal wound.

No alteration was noted intemperature, pulse, blood pressure, random blood sugar, pattern & amount oflochia and after pains.

Goodto excellentgrades were awarded for Saubhagya Sunthi Granules on the GlobalAssessment of overall safety & tolerability by the subjects in theexperimental group.