Effect Of Saubhagya Sunthi Granules in Sutika.
Phase 2
- Conditions
- Health Condition 1: O909- Complication of the puerperium, unspecified
- Registration Number
- CTRI/2019/12/022472
- Lead Sponsor
- Dr Rahulkumar Ramkrushna Kamde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Effect of Study drug on Involution of Uterus, assessed by Symphysis Fundal Height (Day: 0-3; 10-14 post natal) <br/ ><br>2)Effect on color and amount of lochia (Day: 0-3; 10-14; 24-28 post natal)sanitary pad examination. <br/ ><br>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 Outcome Measures
Name Time Method 1)Effect on Lactation (Day: 0-3; 10-14; 24-28; 41-45 post natal) assessed by Neonatal weight gain, urine, stool & sleep pattern <br/ ><br>2)Anti-inflammatory effect on wound; if present (Day: 0-3; 10-14; 24-28; 41-45 post natal) <br/ ><br>3)Global assessment of Overall safety and tolerability of study drug by investigator and the subject at the end of trial. <br/ ><br>Timepoint: Day: 0-3; 10-14; 24-28; 41-45 post natal