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Clinical trial on Pregnant Woman

A Prospective, Randomized, Open Label Study to Evaluate the Safety and Efficacy Of Mulmina Orange Amla Ready To Drink As A Supplement In Pregnant Woman at High Risk for Preeclampsia

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033099
Enrollment
60
Registered
2021-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O111- -2146826259 Health Condition 2: O140- Mild to moderate pre-eclampsia

Interventions

Intervention1: Mulmina Amla Orange ready to drink: Dose: 200ml drink Dosage form: Oral Drink Frequency : 2 packs per day for 4 weeks Route of administrate : Orally Total duration: Day 45 Control Inte

Sponsors

Jagdale industries pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Female volunteer aged more than 18 to 45 years 2.If pregnant, should have completed 1st trimester of the pregnancy 3.Pregnant Woman At High Risk For Preeclamsia 4.Willing to give written consent to participate

Exclusion criteria

Exclusion criteria: 1.Patients with preexisting severe systemic disease necessitating long term medication. 2.Patients with known history of diabetes mellitus. 3.Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation. 4.History of cancer including solid tumors hematologic malignancies and carcinoma in situ 5.Any neurological congenital or acquired vascular or systemic disorder which could affect any of the efficacy assessments. 6.Participation in the current or previous treatment with any approved or investigational health supplements during the past one month.

Design outcomes

Primary

MeasureTime frame
i. Basic Hematology and Biochemistry (TSH profile, LFT, RFT, Lipid profile) ii. Serum immune markers Cohort 1 (IgE, IgD, SOD, TAC) Cohort 2 (EREG, PDGF-D, Folic Acid, Cortisol, TAC, SOD, IgE, IgD, IL-6, IL-10, PGE-2), iii. Urine analysis - Urine pregnancy test Timepoint: Day 0, 14 and 28

Secondary

MeasureTime frame
Assessing the overall health of pregnant womenTimepoint: Day 0 to Day 28

Countries

India

Contacts

Public ContactMr Raghavendra K V

Radiant Research Services Pvt. Ltd

ashok@radiantresearch.in9880999297

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026