Effectiveness of Ayurvedic management and conventional standard care in Gestational Diabetes Mellitus - An open label Randomised Control Trial.

Evaluating the comparative effectiveness of Ayurvedic management and conventional standard care in Gestational Diabetes Mellitus - An open label Randomised Control Trial.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/024392

Enrollment

Registered

2020-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium Health Condition 2: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Ayurvedic treatment: Nishamalaki Talet 500 mg tablet twice a day Sarvaemeha hara kashay 1g once a day 90 days Control Intervention1: Contemprory treatment: Metformin 500 mg for 90

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy with GDM 12 weeks to 34 weeks gestational age with fetus without any known anomalies.

Exclusion criteria

Exclusion criteria: 1.Diabetes diagnosed prior to pregnancy 2.History of stillbirth or fetal death 3. Overt Diabetes 4.Patients with pre-existing renal disease, heart disease and other chronic medical disorders 5. Patient unwilling to participate in the study 6.Known cases of Gestational diabetes on insulin.

Design outcomes

Primary

Measure	Time frame
to achieve glycemic control in patients of Gestational Diabetes. It will be assesssed (Glycemic control fasting 95 mg/dl and 2 hr post parandial 120 mg/dl) To compare the maternal and fetal outcomes in both the groups. Maternal augmentation /Induction of labour , caesarian section, gestational hypertension / preecclampsia) (Fetal outcomes macrosomia 4,000g Shoulder dystocia Apgar score at 1 min 7 Apgar score at 5 min 7 , Neonatal hypoglycemia) Timepoint: It will be assesed weekly after enrollment	—

Measure

Time frame

to achieve glycemic control in patients of Gestational Diabetes. It will be assesssed (Glycemic control fasting 95 mg/dl and 2 hr post parandial 120 mg/dl) To compare the maternal and fetal outcomes in both the groups. Maternal augmentation /Induction of labour , caesarian section, gestational hypertension / preecclampsia) (Fetal outcomes macrosomia 4,000g Shoulder dystocia Apgar score at 1 min 7 Apgar score at 5 min 7 , Neonatal hypoglycemia) Timepoint: It will be assesed weekly after enrollment

—

Secondary

Measure	Time frame
Maternal outcomes Fetal OutcomesTimepoint: After delivery of the baby	—

Countries

India

Contacts

Public ContactDr Charu Sharma

All India Institute of ayurveda

dr.meenakshipathak@gmail.com9984549998

Outcome results

None listed

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