None listed
Conditions
Interventions
Intervention1: Stretch Mark Oil and Stretch Mark Cream: Take sufficient quantity up to 5ml of oil /cream and apply gently on the stretch marks prone area (Group-I - preventive) and on the stretch mark
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: Aged >= 18 years at recruitment. Primigravid women. Singleton pregnancy. Women with one of the following: Pregnant women between 12â??14 weeks of gestation with absence of abdominal striae (for Group I). Post-Partum women with normal and C-section delivery and visible stretch marks (will be enrolled at the time of discharge- Post-partum - Group-II) Willing to participate and continue with the study follow-ups.
Exclusion criteria
Exclusion criteria: Multigravida women (due to risk of having striae from an earlier pregnancy) or with already existing striae from earlier weight loss or any other reasons. Women taking corticosteroids for any reason (due to their association with skin striae). High risk pregnancy. Bad obstetric history. Any risk/ infection known to develop congenital anomaly in the baby (TORCH infections). Multiple pregnancies (due to increased maternal weight gain and skin stretching). Women with a known hypersensitivity to agents in formulation (due to risk of allergic reaction). Women with known disorders or illnesses that maybe associated with striae, e.g. Marfan syndrome, Cushing syndrome. Women who decline to discontinue other creams or lotions. Women who are unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Appearance of striae Visible changes/improvement in the stretch marks, (including the severity, and, color). Changes /improvement in relief of associated symptoms such as dryness, itching, moisturization and skin texture by using VAS scale Evaluation for reduction/treatment of stretch marks (including the severity and color) post-delivery the stretch marks Improvement in skin elasticity and firmness of skin by Elastimeter.Timepoint: visit 1, visit 2, visit 4, and visit 6, at the time of discharge, visit 8 and visit 9. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevention of visible appearance of stretch marks during the pregnancy (starting the application from13thweek (± 1 week) of pregnancy). Relief of associated symptom such as dryness and itchiness during pregnancy and post-partum. Monitor any adverse events. Timepoint: visit 1, visit 2, visit 4, and visit 6, at the time of discharge, visit 8 and visit 9. | — |
Countries
India
Contacts
Public ContactDivya C
BioAgile Therapeutics Pvt Ltd
Outcome results
None listed