| CTRI Number |
CTRI/2023/07/054782 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of constitutional Homoeopathic Medicine in treatment of Sickle Cell Disease |
|
Scientific Title of Study
|
ROLE OF CONSTITUTIONAL HOMOEOPATHIC MEDICINE IN TREATMENT OF SICKLE CELL DISEASE |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Bhimani |
| Designation |
BHMS, MD Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Dept. of Organon of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Limda, Vadodara - Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9173099774 |
| Fax |
|
| Email |
kpatel511.kp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Partha Sarthi Mandal |
| Designation |
Professor & HoD |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Dept. of Organon of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Limda, Vadodara - Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9375095471 |
| Fax |
|
| Email |
mandalpartha58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Partha Sarthi Mandal |
| Designation |
Professor & HoD |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Dept. of Organon of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Limda, Vadodara - Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9375095471 |
| Fax |
|
| Email |
mandalpartha58@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medicine OPD, Jawaharlal Nehru Homoeopathic Medical Hospital, Parul University, Vadodara |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [SELF] |
|
|
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 Komal Bhimani |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
Dept. of Organon of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Limda, Vadodara - Gujarat.
Vadodara
GUJARAT |
9173099774
kpatel511.kp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D70-D77||Other disorders of blood and blood-forming organs, (2) ICD-10 Condition: D571||Sickle-cell disease without crisis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Constitutional Medicine |
Dose: 200, 1M potency
Route: Oral (Sub-lingual) Administration
Duration: 6-9 Months
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Above 18 years age
New diagnosed and pre - diagnosed cases of SCD
Both sexes.
Samples are selected according to sickling positive blood test and clinical signs of individual patient.
Those subjects whose willing take part in the study and sign the written informed consent. |
|
| ExclusionCriteria |
| Details |
Cases which Suffering from other severe systemic diseases.
Acute crisis where hospitalization required
Pregnant & lactating woman
Cases with Irreversible pathologies
Irregular follow ups |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Blood indices including Hb%
MCV MCH |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS Scale (Visual Analogue Scale) Assessment |
3, 6, 9 Months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Sickle cell disease results from an abnormal haemoglobin known as Haemoglobin-S (Hb-S) or sickle haemoglobin. The molecular lesion in Hb-S is the substitution of valine for glutamic acid at the sixth residue of β-chain. (1) Sickle cell anemia in homozygous state for the Hb-S gene (Hb-SS). Sickle cell trait in heterozygous state (Hb-AS). In 2015 (WHO) study shows data of disease in a year 4.4 million have sickle cell disease and 43 million have sickle cell trait and 1,14,800 deaths due to sickle cell. In India approximately 1 million cases per year suffering from Sickle cell Disease. In South India, Assam, Bihar, Orissa. In Africa 1 out of 13 newborn 1 child have sickle cell trait. As SCD cases 50% dies up-to the age of 40 year, 10% dies within their first decade of life and takes everyday painkillers & repeated Blood transfusion. Goal is to enhance the life expectancy of SCD patient we need to help and spare the patient from these daily medications. Folic acid and Hydroxyurea are the only medication in allopathic side for lifelong management. Need to see the effectiveness of homoeopathic medicine in treatment of sickle cell diseases and reduce the severity of complications which are caused by SCD. Anaemia is the major sign in sickle cell disease. Thus, anaemia also has an impact on daily working capacity and its impact on the future economy of person as well as country. As the disease is chronic in character requisite the constitutional homoeopathic medicine to prevent various complication. Constitution of a person is formed from the mind as well as the body of a person. As every person is different, the medicine selected to treat a patient differs from person to person. The present study of "ROLE OF CONSTITUTIONAL HOMOEOPATHIC MEDICINE IN TREATMENT OF SICKLE CELL DISEASE "chosen with an aim to understand the clinical presentation of inherently transmitted Sickle cell Disease and to study the role of homoeopathy in the management of Sickle cell Disease. Totality of Symptoms has been made to individualize the case. If we can manage Sickle Cell Disease or can reduce the complaints of patient with the help of Homoeopathic medicine, then it will fulfil our goal. |