Health Condition 1: O909- Complication of the puerperium, unspecified
Conditions
Interventions
Intervention1: Saubhagya Sunthi Granules: Saubhagya Sunthi Granules
5 gram BD Per Oral
From First to 42nd day Post natal
Control Intervention1: No Medicinal Intervention: Tribal Patients will follow t
Sponsors
Dr Rahulkumar Ramkrushna Kamde
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers willing to participate as a clinical trial subject and giving written consent. Age between 18 to 45 years. Woman with uncomplicated vaginal delivery with or without episiotomy. Woman with mild anemia Hb% 7 gm or more, will be included.
Exclusion criteria
Exclusion criteria: Volunteers not willing to participate or not giving consent will be excluded. Woman with serious post natal complications namely Severe PPH, Shock, Eclampsia, Uterine Inversion. Severe anemia Hb% less than 7 gm. Woman with known sensitivity or allergy to any of the ingredient(s) of the Study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Effect of Study drug on Involution of Uterus, assessed by Symphysis Fundal Height (Day: 0-3; 10-14 post natal) 2)Effect on color and amount of lochia (Day: 0-3; 10-14; 24-28 post natal)sanitary pad examination. 3)Effect on After Pains (Day: 0-3; 10-14; 24-28; 41-45 post natal) assessed by VAS scaleTimepoint: Day: 0-3; 10-14; 24-28; 41-45 post natal | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Effect on Lactation (Day: 0-3; 10-14; 24-28; 41-45 post natal) assessed by Neonatal weight gain, urine, stool & sleep pattern 2) Anti-inflammatory effect on wound; if present (Day: 0-3; 10-14; 24-28; 41-45 post natal) 3) Global assessment of Overall safety and tolerability of study drug by investigator and the subject at the end of trial. Timepoint: Day: 0-3; 10-14; 24-28; 41-45 post natal | — |
Countries
India
Contacts
Public ContactDr Swati Surendra Mohite
Bharati Vidyapeeth (Deemed to be University), College of Ayurved, Pune-Satara Road, Pune-411043
Outcome results
None listed