Sickle Cell Disease and Homoeopathy

Phase 3

Not yet recruiting

• Conditions: Sickle-cell disorders,

• Registration Number: CTRI/2025/05/087353
• Lead Sponsor: Central Council for Research in Homoeopathy

Brief Summary

The single blind, randomized, placebo controlled trial will be undertaken at 1 centre  providing standard OPD care for Sickle cell disease with an objective to evaluate the  efficacy ofadjuvant homoeopathic treatment in management of Sickle Cell Disease by : Assessing change in frequency, intensity and durationof acuteVaso-occlusive pain crisis episode,  Assessing number of blood transfusions required, Assessing change in haematological parameters ascompared to baseline, Assessing loss of daily wages due to missed days ofwork and Assessment of quality of life based on Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) at baseline, 6 months and 12months

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-06
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Diagnosed patient of Sickle Cell Disease with reported episodes of acute vaso-occlusive crisis anytime in last 3 months Individuals with vaso occlusive crisis on day of enrollment will be enrolled after the episode of acute crisis is over.

Exclusion Criteria

• Individuals having any severe complication of sickle cell disease like acute chest syndrome (ACS), aseptic necrosis of bone, etc.
• Individuals with any another hemolytic anemia such thalassemia, G6PD, hereditary spherocytosis, hemolytic uremic syndrome, etc.
• Individuals who have had bone marrow transplantation Individuals with self reported addictions to alcohol, severe end stage comorbidities like stroke, end stage kidney disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in frequency, duration and intensity (FDI) of acute Vaso-occlusive pain crisis episodes	Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.
Frequency will be measured as number of episodes each week	Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.
Duration will be measured as number of days with pain severe enough to affect daily activities	Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.
Intensity will be measured on VAS scale as the most severe pain occurring anytime during the acute episode	Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.
Number of blood transfusions required during the follow up period	Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.

Secondary Outcome Measures

Name	Time	Method
Change in hematological and biochemical parameters at 6 months and at 12 months as compared to baseline	oHaemoglobin

Trial Locations

Locations (1)

C.N. Kothari Homoeopathic Medical College and Research Centre; 🇮🇳 Surat, GUJARAT, India

C.N. Kothari Homoeopathic Medical College and Research Centre

🇮🇳Surat, GUJARAT, India

Dr Jyoti Rao

Principal investigator

9099064866

cnkotharicollege@gmail.com