Health Condition 1: B749- Filariasis, unspecified
Conditions
Interventions
Intervention1: AyushSL: Tablet formulation given twice a day.
Duration of therapy-12 weeks
Follow up-24 weeks
Control Intervention1: Placebo: Nil
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Any clinically diagnosed case of filariasis with-Positive ICT or ELISA or MF (with documentary evidence) (having documentary evidence) 2. Diagnosis of filarial lymphoedema for at least 1 year (Documentary evidence or Patient history/narration) 3. Manifested cases of Filariasis with lymphoedema of Grade - I & Grade - II (lower limbs) 4. History of taking the Mass Drug Administration dosing within last five months (but not within last one week with documentary evidence) [Showing Valid Proof) 5. Patients willing to give informed consent
Exclusion criteria
Exclusion criteria: 1. Diagnosis of filarial lymphoedema more than 5 years as evidenced by supporting documents (prescription, laboratory diagnosis report, clinical profile etc.) 2. Presence of deformity (nodular deformity, thorny deformity, anthill like deformity), oedema of other origins (Myxoedema etc.) 3. History of continued medication for treatment of any chronic disease like, epilepsy, chronic liver disease, chronic kidney disease, Ischemic Heart Disease and Congestive Cardiac Failure. 4. Uncontrolled diabetes mellitus(HBA1C > 7.5), Hypertensive cases taking diuretics 5. Patients on tetracycline therapy 6. Hb levels less than or equal to 9 g/dL 7. Pregnancy (to be confirmed by lab test) or lactation 8. Acute cases of Acute Dermato-Lymphangio Adenitis (ADLA) without any features of filarial lymphedema 9. Patients with history of alcoholism/ drug dependence may be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction of edema a. Lower Limb Measurements b.Limb - From anterior superior iliac spine (ASIS) to ground at 90 degree c. Foot - From medial side d. Foot - From lateral side e. Maximum circumference of calf f. Maximum circumference of mid-thigh g. Maximum circumference of patellar h. Circumference of ankle i. Circumference of mid-foot j. Circumference of foot joining the heads of the metatarsals 2. Volume Displacement MeasurementTimepoint: 1. Baseline 2. At the end of 4 weeks(28th day) 3. At the end of 12 weeks (84th day) 4. Follow up(without medicine) at the end of 24th weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in Quality of Life (QoL) 2. Prevention of recurrence of acute episodes Timepoint: 1. Baseline 2. At the end of 12 weeks (84th day) 3. Follow up(without medicine) at the end of 24th weeks. | — |
Countries
India
Contacts
Public ContactSantanu Kumar Tripathi
School of Tropical Medicine Kolkata
Outcome results
None listed