Health Condition 1: Z391- Encounter for care and examinationof lactating mother
Conditions
Interventions
Intervention1: Metabolically Lean Postpartum capsule: One Metabolically Lean Postpartum capsule is to be taken orally once daily after lunch with a glass of water for 90 days.
Control Intervention1: N
Sponsors
Seven Turns Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy lactating females aged between 21 to 40 years both inclusive 2.Participant with a BMI between 30 to 35 kg per m both inclusive 3.Participant with waist circumference greater than 31.5 inches or 80 cm 4.Women who are within the postpartum period specifically 16 to 20 weeks after delivering a full term infant 5.Providing voluntary written informed consent to participate in the study 6.Participants without comorbidity.
Exclusion criteria
Exclusion criteria: 1.Non-lactating or pregnant women 2.Women currently receiving or who have received weight loss medications or supplements within the past 3 months 3.History of or current diagnosis of type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM), and gestational diabetes mellitus (GDM), or hypothyroidism 4.Presence of significant medical conditions or contraindications that would interfere with participation in the study or affect the safety of the investigational product 5.Women who experienced significant pregnancy related complications that could impact weight or health status like severe preeclampsia major postpartum hemorrhage, hemorrhoids 6.Women who have undergone major surgery within the last 3 months except for delivery 7.Participants with heavy alcohol consumption or smoking or tobacco consumption 8.Participation in other clinical trials in the last 90 days prior to screening 9.Any condition that could in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of changes in hematological and biochemical parameters [complete blood count (CBC), liver function test (LFT), renal function test (RFT), lipid profile] Assessment of compliance and tolerability of the investigational product. Assessment of adverse events profile in mother and infant (sleep disturbances, incidences of crying, & stool pattern). Timepoint: 1.At screening, day 30, day 60, and day 90. 2.At day 30, day 60, and day 90. 3.At day 1, day 30, day 60, and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of changes in anthropometric parameters such as body weight (kg), and BMI 2.Assessment of changes in waist measurement (loss in inches) . 3.Assessment of changes in body weight and height of infant 4.Assessment of changes in the Edinburgh Postnatal Depression. Scale (EPDS) score . 5.Assessment of changes in Hamilton Anxiety Rating Scale (HAM-A) score . 6.Assessment of changes in Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) scale scoreTimepoint: 1.At screening, day 30, day 60, and day 90. 2.At screening, day 30, day 60, and day 90. 3.At screening, day 30, day 60, and day 90. 4.At screening and day 90 5.At screening and day 90. 6.At screening and day 90. | — |
Countries
India
Contacts
Public ContactKaynat Mirajkar
Seven Turns Pvt. Ltd.
Outcome results
None listed