| CTRI Number |
CTRI/2025/05/087353 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Sickle Cell Disease and Homoeopathy |
|
Scientific Title of Study
|
Efficacy of Adjuvant Homoeopathic Treatment in Sickle Cell Disease - A Pilot, Single-Blind, Randomized, Placebo-Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renu Mittal |
| Designation |
Research Officer/ Scientist-4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65 Institutional Area, opposite D-block, New Delhi- 110058
South West
DELHI
110058
India
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
28521060 |
| Email |
renumittal8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Mittal |
| Designation |
Research Officer/ Scientist-4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65 Institutional Area, opposite D-block, New Delhi- 110058
South West
DELHI
110058
India
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
28521060 |
| Email |
renumittal8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer/ Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65 Institutional Area, opposite D-block, New Delhi- 110058
South West
DELHI
110058
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
28521060 |
| Email |
drdivyataneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, Jawahar Lal Nehru
Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area,
Opposite D Block Janakpuri, New Delhi, India, Pincode-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, Jawahar Lal Nehru
Chikitsa Avum Anusandhan Bhawan, 61-65, Institutional Area,
Opposite D Block Janakpuri, New Delhi, India, Pincode-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti Rao |
C.N. Kothari Homoeopathic Medical College and Research Centre |
Department of Community Medicine, 2nd Floor C.N. Kothari Homoeopathic Medical College & R.C. Vyara.
Vilasini K. Desai Arogya Sankul,
Near Vanchetna,
Kakrapar bypass,
Tadkuva,
VYARA,
Dist.-TAPI,
GUJARAT-INDIA
Surat
GUJARAT |
9099064866
cnkotharicollege@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D57||Sickle-cell disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Standard care with Individualized Homoeopathic medicine |
Homoeopathic Medicines in compliance with pharmacopoeial standards from GMP compliant manufacturers would only be used. The medicine would be taken orally in form of pills (sugar globules) saturated with homoeopathic dilutions for 12 months. |
| Comparator Agent |
Standard care with Placebo |
Identical placebo saturated with 20% ethyl alcohol for 12 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in frequency, duration and intensity (FDI) of acute Vaso-occlusive pain crisis episodes
Frequency will be measured as number of episodes each week
Duration will be measured as number of days with pain severe enough to affect daily activities
Intensity will be measured on VAS scale as the most severe pain occurring anytime during the acute episode
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
|
| Outcome |
TimePoints |
Change in hematological and biochemical parameters at 6 months and at 12 months as compared to baseline
o Haemoglobin
o TIBC (Total Iron Binding Capacity)
o Red cell count
o PCV (Packed Cell Volume)
o MCV (Mean Corpuscular Volume)
o MCH (Mean Corpuscular Haemoglobin)
o MCHC (Mean Corpuscular Haemoglobin Concentration)
o RDW (Red Cell Distribution Width)
o Reticulocyte count
o Serum ferritin
o Serum iron
o Vitamin B12
o Folic acid
o Liver Function Test
o Renal Function Test
o Peripheral smear
o Transferrin saturation percentage
Number of days of missed work and loss of daily wages
Assessment of quality of life based on Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) at baseline, 6 month and 12 months
|
Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months. |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 of
adjuvant homoeopathic treatment in management of Sickle Cell Disease by : Assessing change in frequency, intensity and duration
of acute
Vaso-occlusive pain crisis episode, Assessing number of blood transfusions required, Assessing change in haematological parameters as
compared to baseline, Assessing loss of daily wages due to missed days of
work and Assessment of quality of life based on Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) at baseline, 6 months and 12
months |