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Assessment of changes in blood parameters among lymphatic filariasis patients following integrative treatment

Novel Circulating Protein Fingerprints for Therapeutic Monitoring of Lymphoedema Reversal Following the Integrative Treatment - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098572
Enrollment
120
Registered
2025-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: B749- Filariasis, unspecified

Interventions

Intervention1: Integrative treatment: The components of integrative treatment for lymphatic filariasis are
skin wash with soap and water, phanta soaking, yoga and pranayama, Indian manual lymph drainage (IMLD) and compression therapy. The Phanta is an Ayurvedic herbal solution in which, the limb is dipped

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Provisional Diagnosis of Lymphatic Filariasis Patients with ISL Grade 2 (Early or Late) or Grade 3 lymphoedema with brawny/organized oedema

Exclusion criteria

Exclusion criteria: Patients currently or recently have experienced an acute inflammatory episode (cellulitis/filarial fever/ADLA) during the previous month of reporting. Other causes of lymphoedema determined clinically, such as traumatic, secondary or genetic lymphoedema. Pregnancy or lactation The patients who consumed systemic corticosteroids, immunosuppressive drugs, or anti- inflammatory treatments (as a course) in the past 2 months. Patients with history of major chronic illness or communicable disease (Active cancer, Tuberculosis, Autoimmune diseases, HIV, Hepatitis B, Hepatitis C), Patients with chronic kidney disease greater than Stage 3, Patients with chronic diabetes (if RBS is greater than 300 mg/dL)

Design outcomes

Primary

MeasureTime frame
Quantitative change in collagen turnover biomarkers (MMPs, TIMPs, lysyl oxidase, hydroxyproline) in serum/plasma/urine samples before and after 14 days of Integrative Medical (IM) treatment. Identification of differentially expressed proteins through mass spectrometry that correlate with lymphoedema reversal. Correlating clinical outcomes (such as limb volume changes) with molecular and biochemical markers.Timepoint: 3 years

Secondary

MeasureTime frame
Establishment of a reference proteome map for lymphoedema in Lymphatic Filariasis. Validation of candidate biomarkers using Western blotting and/or PCR from plasma samples. Assessment of biochemical parameters (e.g., liver/kidney function, lipid profile, calcium, ceruloplasmin, copper/zinc) pre- and post-treatment.Timepoint: 3 years

Countries

India

Contacts

Public ContactDr. S. R. Narahari

Institute of Applied Dermatology

srniad@gmail.com9388010022

Outcome results

None listed

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