A Clinical Trial to study the effect of Kokilaksha Extract in the management of Iron Deficiency Anaemia

An Open Labelled Active Controlled Randomized Clinical Study to Evaluate the Efficacy of Ethanolic Extract of Kokilaksha (Asteracantha longifolia Nees.) in the Management of Iron Deficiency Anemia - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065535

Enrollment

Registered

2024-04-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: D508- Other iron deficiency anemias

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients fulfilling the diagnostic criteria of Iron Deficiency Anemia. a. Based on Symptoms b. Hemoglobin less than 130gm/L in males, less than 120gm/L in Females, less than 110gm/L in pregnancy. c. Sr. Ferritin Reduced, Male:24 to 336ng/L, Female:24 to 336ng/L. d. TIBC Raised 262 to 474mcg/dl. e. Sr. Iron Reduced, women:26 to 170, Men:76 to 198. f. MCV Low 80-100 Femtolitre. g. Mentzer’s index - greater than 13 Iron Deficiency anemia. 2. Patients belonging to age group of 18 -60 years (both inclusive) of either sex irrespective of religion, socio economic status, etc. 3. Patient willing and able to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with history of congenital disorders related with haemopoietic system like SCA, Leukemia & hemophilia. 2. Patients with history of other systemic diseases like uncontrolled diabetes mellitus and hypertension. 3. Patients suffering from disorder of the GIT system associated with Gastrointestinal bleeding like colorectal malignancy, gastritis, peptic ulceration & inflammatory bowel disease. 4. Patients on chronic use of aspirin & NSAIDS. 5. Pregnant & lactating women. 6. Immunocompromised Patients-HIV. 7. Patients on prolonged medication (more than 6 weeks) with corticosteroids, or any other drugs that may have influence on the outcome of the study. 8. Patients who are currently participating in any other clinical trials (since last 2 months).

Design outcomes

Primary

Measure	Time frame
1.Changes in the Complete Blood Count between the group (Pre and Post) 2. Changes in the Total Iron Binding Capacity between the group (pre and post) 3. Changes in the Serum Iron between the group (pre and post) Timepoint: Baseline Visit (Day 0) and Day 60	—

Secondary

Measure	Time frame
Clinical sign & symptoms of Iron deficiency anemia viz. Pallor, Weakness, Fatigue, Anorexia, Palpitations, Dyspnoea, Reduced Exercise capacity, Headache, Giddiness etc. Will be given Scoring pattern & will be analysed before, during & after treatmentTimepoint: Baseline visit, Day 0 ,Day 15, Day 30, Day 45, Day 60;Compare the efficacy of ethanolic extract of Kokilaksha with ferrous sulphate on CBC, Serum Iron, TIBC. in the Patients of Iron Deficiency AnemiaTimepoint: Baseline, Day 15, Day 30, Day 45, Day 60	—

Measure

Time frame

Clinical sign & symptoms of Iron deficiency anemia viz. Pallor, Weakness, Fatigue, Anorexia, Palpitations, Dyspnoea, Reduced Exercise capacity, Headache, Giddiness etc. Will be given Scoring pattern & will be analysed before, during & after treatmentTimepoint: Baseline visit, Day 0 ,Day 15, Day 30, Day 45, Day 60;Compare the efficacy of ethanolic extract of Kokilaksha with ferrous sulphate on CBC, Serum Iron, TIBC. in the Patients of Iron Deficiency AnemiaTimepoint: Baseline, Day 15, Day 30, Day 45, Day 60

—

Countries

India

Contacts

Public ContactDr Rinjin G Krishna

Parul Institute of Ayurveda

rinjin.krishna17658@paruluniversity.ac.in8921093277

Outcome results