Evaluation of the Safety, Effectiveness, and Benefits of Tapyadi Loha in Treating Sickle Cell Anemia

To determine the anti-sickling and antioxidant activity of tapyadi loha through in vitro study and to evaluate the safety, efficacy and tolerability of tapyadi loha in sickle cell anemia through pilot clinical study. - nill

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087392

Enrollment

Registered

2025-05-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: D571- Sickle-cell disease without crisis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Non pregnant, non lactating woman. 2. Diagnosed case of sickle cell anemia 3. Willing to give written informed consent for participation in the trial as well as willing and able to comply with study visit schedule and other protocol requirements.

Exclusion criteria

Exclusion criteria: 1. K/C/O HIV antibody, HBsAg or HCV antibody 2. Alcohol or any drug dependence within past one year. 3. Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening 4. Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening 5. Patients having acute phase of crisis and with various complication such as stroke, renal failure, spleen infraction, transfusional iron overload and Recently blood transfused individuals.

Design outcomes

Primary

Measure	Time frame
1.Maintenance of Hb levels 2.Frequency-duration- intensity of crises 3.Requirement of in-patient hospitalization 4.Number of days of hospitalization 5.Requirement of intensive care 6.Quality of life. Timepoint: 1.Maintenance of Hb levels - 0th Day 30th and 60th Day 90th Day 2.Frequency-duration- intensity of crises - 0th Day 30th and 60th Day 90th Day 3.Requirement of in-patient hospitalization - 0th Day 30th and 60th Day 90th Day 4.Number of days of hospitalization - 0th Day 30th and 60th Day 90th Day 5.Requirement of intensive care - 0th Day 30th and 60th Day 90th Day 6.Quality of life- 0th Day 30th and 60th Day 90th Day	—

Measure

Time frame

1.Maintenance of Hb levels 2.Frequency-duration- intensity of crises 3.Requirement of in-patient hospitalization 4.Number of days of hospitalization 5.Requirement of intensive care 6.Quality of life. Timepoint: 1.Maintenance of Hb levels - 0th Day 30th and 60th Day 90th Day 2.Frequency-duration- intensity of crises - 0th Day 30th and 60th Day 90th Day 3.Requirement of in-patient hospitalization - 0th Day 30th and 60th Day 90th Day 4.Number of days of hospitalization - 0th Day 30th and 60th Day 90th Day 5.Requirement of intensive care - 0th Day 30th and 60th Day 90th Day 6.Quality of life- 0th Day 30th and 60th Day 90th Day

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Secondary

Measure	Time frame
1) To determine the safety and tolerability of Tapyadi Loha in Sickle cell anemia on the basis of occurrence/ severity/ requirement of medicine/ causality assessment of adverse event.Timepoint: 1) To determine the safety and tolerability of Tapyadi Loha in Sickle cell anemia on the basis of occurrence/ severity/ requirement of medicine/ causality assessment of adverse event. -0th Day -30th and 60th Day -90th Day	—

Measure

Time frame

1) To determine the safety and tolerability of Tapyadi Loha in Sickle cell anemia on the basis of occurrence/ severity/ requirement of medicine/ causality assessment of adverse event.Timepoint: 1) To determine the safety and tolerability of Tapyadi Loha in Sickle cell anemia on the basis of occurrence/ severity/ requirement of medicine/ causality assessment of adverse event. -0th Day -30th and 60th Day -90th Day

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Countries

India

Contacts

Public ContactDr Suchita Ware

Parul Institute Of Ayurved And Research

dr.vaishalid@gmail.com9096082950

Outcome results