| CTRI Number |
CTRI/2023/05/053051 [Registered on: 23/05/2023] Trial Registered Prospectively |
| Last Modified On: |
19/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Moringa oleifera Mother Tincture in Treatment of anemia |
|
Scientific Title of Study
|
Clinical effectiveness of Moringa oleifera Mother Tincture in Treatment of anemia - A single arm Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Sahani |
| Designation |
Lecturer |
| Affiliation |
RBTS Gov. Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory,
RBTS Govt Homoeopathic Medical College and Hospital, Ramdayalu Nagar, PO - Ramna, Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
7765802619 |
| Fax |
|
| Email |
amitrisdth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashutosh Kumar |
| Designation |
Lecturer |
| Affiliation |
RBTS Gov. Homoeopathic Medical College and Hospital |
| Address |
Department of Anatomy,
RBTS Govt Homoeopathic Medical College and Hospital, Ramdayalu Nagar, PO - Ramna, Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
7004832173 |
| Fax |
|
| Email |
drashutosh786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujeet Kumar |
| Designation |
Medical Officer |
| Affiliation |
RBTS Gov. Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine,
RBTS Govt Homoeopathic Medical College and Hospital, Ramdayalu Nagar, PO - Ramna, Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
9835470983 |
| Fax |
|
| Email |
dr.sujeet81@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Govt Homoeopathic Medical College and Hospital,
Ramdayalu Nagar, PO - Ramna,
Muzaffarpur - 842002, Bihar, India |
|
|
Primary Sponsor
|
| Name |
Dr Amit |
| Address |
RBTS Govt Homoeopathic Medical College and Hospital, Ramdayalu Nagar, PO Ramna, Muzaffarpur, Bihar |
| 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 Amit |
RBTS Govt Homoeopathic Medical College and Hospital |
Department of Repertory,RBTS Govt Homoeopathic Medical College and Hospital, Ramdayalu Nagar, PO Ramna, Muzaffarpur - 842002, Bihar
Muzaffarpur
BIHAR |
7765802619
amitrisdth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D53||Nutritional anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Hemoglobin percent between 8 to 12 gm%
2. Self reported & pre-diagnosed cases of anaemia.
3. Patients with symptomatology of anaemia.
4. Patients volunteering
|
|
| ExclusionCriteria |
| Details |
1. Hemoglobin percent less tha 8gm% and more than 12 gm%
2. Patients unwilling to take part or not giving consent to join the study.
3. Diagnosed cases of systemic diseases, psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
4. Substance abuse and/ or dependence.
iv. Self reported immune-compromised state.
5. Undergoing homoeopathic treatment for any chronic disease within the last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate whether Moringa oleifera mother tincture can produce improvement in cases of anemia |
Baseline, One month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any effect on quality of life |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Concern regarding health improvement in anaemia affected patient with
the treatment by Moringa oleifera mother tincture. In fact with the help of
conventional medical treatment anaemia relieves temporary, but it produces
adverse effects as well. So, many patient using alternative therapy for
this. Several pharmacological and non-pharmacological treatments appear to be
ineffective, and patients are frequently suffer from recurrency of anaemia. Homoeopathy,
which is not only productive but also cost effective in comparison to other
modes of treatment, offers a vast number of medicines capable of treating the anaemia
of the patients by individualisation. |