Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: Ashwagandha Root Extract (300 mg) Capsule plus Standard Hematinics: Capsule containing Ashwagandha Root Extract (300 mg) two times a day (total 600 mg/day) plus Standard Hematinics for
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pregnant women aged between 18 and 35 years. 2.Pregnant women 12 to 24 weeks (second trimester) of pregnancy with a normal pregnancy status, without significant comorbid conditions. 3.Willing and able to follow the study protocol, including attending regular follow-up visits. 4.Provide written informed consent after understanding the study s risks, benefits, and protocol details.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin,RBC indices (red blood cell count (RBC), hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and red cell distribution width (RDW).Timepoint: Baseline, Week 4, Week 8, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical adverse events, either spontaneously reported by the patient, or noticed by the physician will be recorded during the therapy.Timepoint: Baseline, Week 4, Week 8, Week 12;Laboratory adverse events based on hepatic function tests (serum bilirubin, serum proteins, transaminases, alkaline phosphatase) and renal function tests (serum creatinine, BUN).Timepoint: Baseline, Week 12;Maternal stress assessed using the Perceived Stress Scale [PSS-10].Timepoint: Baseline, Week 4, Week 8, Week 12;Maternal sleep quality assessed using the Pittsburgh Sleep Quality Index [PSQI].Timepoint: Baseline, Week 12 | — |
Countries
India
Contacts
Public ContactDr Ashutosh Ajgaonkar
Trupti Hospital
Outcome results
None listed