Evaluating the effect of Haridradi Kashaya Ghana capsule on breast milk quality in lactating mothers.

Efficacy of Haridradi Kashaya Ghana (capsule) in the management of Stanyadushti (vitiated breast milk) in lactating mothers: A double blind randomized placebo controlled clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082580

Enrollment

Registered

2025-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: R888- Abnormal findings in other body fluids and substances

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Lactating mothers having infants in the age group of 15 days to 06 months of either sex irrespective of the health condition of the infants. 2. Lactating mothers with infants who are on exclusive breast milk feeding. 3. In lactating mothers, on breast milk examination, presence of at least two parameters of Stanyadushti (vitiated breast milk). 4. Mothers who are willing to enroll self and their children in the study with a written consent. 5. Mothers who are willing to give breast milk samples.

Exclusion criteria

Exclusion criteria: 1. Mothers who are not willing to participate. 2. Mothers with preterm delivery. 3. Infant taking top/formula feed. 4. Mother contraindicated for breastfeeding. 5. Mother taking any medication for any disease. 6. Any behavioral condition of the mother that could affect subject s ability to accurately report the symptoms of the baby. 7. Pathological neonatal hyperbilirubinemia and its sequelae. 8. Infant with congenital anomalies, metabolic and neurological conditions. 9. Known allergy to any content of Haridradi Kashaya Ghana (capsule) to mothers and child.

Design outcomes

Primary

Measure	Time frame
Attaining at least two normal breast milk (Shuddha Stanya) parameters on breast milk examination.Timepoint: Baseline and on 15th day	—

Secondary

Measure	Time frame
Changes in the level of Lactoferrin and alpha Lactalbumin in breast milkTimepoint: Baseline and on 15th day;Absence of symptoms of Stanydushti (vitiated breast milk) Normal growth parameters in the infant (Weight length Head circumference) Normal developmental milestones of the infant Absence of symptoms of Rasa Dhatu Dushti Changes in the score of SF 12 questionnaire of maternal healthTimepoint: Baseline 15th day 71st day	—

Measure

Time frame

Changes in the level of Lactoferrin and alpha Lactalbumin in breast milkTimepoint: Baseline and on 15th day;Absence of symptoms of Stanydushti (vitiated breast milk) Normal growth parameters in the infant (Weight length Head circumference) Normal developmental milestones of the infant Absence of symptoms of Rasa Dhatu Dushti Changes in the score of SF 12 questionnaire of maternal healthTimepoint: Baseline 15th day 71st day

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Countries

India

Contacts

Public ContactDr Mahapatra Arun Kumar

All India Institute of Ayurveda

srajagopala@gmail.com7600902564

Outcome results