| CTRI Number |
CTRI/2024/06/068240 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Action of Moringa mother tincture in management of iron deficiency anaemia in young females |
|
Scientific Title of Study
|
A comparative study to improve Hb percentage in Anaemic women using Moringa Oleifera Mother Tincture Versus Constitutional Homoeopathic Remedies in Rural areas in Belgavi. |
| 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 Rinku Porwal |
| Designation |
Associate Professor |
| Affiliation |
KLE Homoeopathic Medical College and Hospital |
| Address |
KLE Homoeopathic Medical College and Hospital
Homoeopathic OPD
Medicine Department
KLE Homoeopathic Medical College and Hospital
YELLUR ROAD
BELAGAVI- 590005
Belgaum
KARNATAKA
590005
India |
| Phone |
09916987766 |
| Fax |
|
| Email |
romagporwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rinku Porwal |
| Designation |
Associate Professor |
| Affiliation |
KLE Homoeopathic Medical College and Hospital |
| Address |
KLE Homoeopathic Medical College and Hospital
HOmoeopathic OPD
Medicine Department
KLE Homoeopathic Medical College and Hospital
YELLUR ROAD
BELAGAVI- 590005
Belgaum
KARNATAKA
590005
India |
| Phone |
09916987766 |
| Fax |
|
| Email |
romagporwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinku Porwal |
| Designation |
Associate Professor |
| Affiliation |
KLE Homoeopathic Medical College and Hospital |
| Address |
KLE Homoeopathic Medical College and Hospital
Homoeopathic OPD
Medicine Department
KLE Homoeopathic Medical College and Hospital
YELLUR ROAD
BELAGAVI- 590005
Belgaum
KARNATAKA
590005
India |
| Phone |
09916987766 |
| Fax |
|
| Email |
romagporwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER
JNMC campus
Nehru Nagar
BELAGAVI- 590010
KARNATAKA INDIA |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
JNMC campus
Nehru Nagar
Belagavi
590010
KARNATAKA
INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 RINKU PORWAL |
KLE Homoeopathic Medical Hospital |
KLE Centenary Charitable Hospital
KLE Homoeopathic Medical Hospital
Homoeopathic OPD
Medicine department
YELLUR ROAD.
BELAGAVI-590005
Belgaum
KARNATAKA |
09916987766
romagporwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KAHERS Shri B M Kankanwadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
constitutional Homoeopathic remedy |
Intervention: 1. 10 drops of Moringa mother tincture in a glass of water twice a day before food will be given to 30 female subjects with Anaemia (group A) 2. Constitutional Homoeopathic medicine will be given to 30 female subjects with Anaemia (group B) 3. The drug under trial will be administered for 6 months. 4. Follow-up: Every case will be followed up once in 30 days for a minimum period of 6 Months. 5. Hemoglobin gram % will be assessed every month to estimate the before and after effects of medications on the Subjects. The hemoglobin will be estimated in the standardized auto analyzer. |
| Intervention |
Moringa mother tincture |
Intervention:
1. 10 drops of Moringa mother tincture in a glass of water twice a day before food will be given to 30 female subjects with Anaemia (group A)
2. Constitutional Homoeopathic medicine will be given to 30 female subjects with Anaemia (group B)
3. The drug under trial will be administered for 6 months.
4. Follow-up: Every case will be followed up once in 30 days for a minimum period of 6 Months.
5. Hemoglobin gram % will be assessed every month to estimate the before and after effects of medications on the Subjects. The hemoglobin will be estimated in the standardized auto analyzer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Females between the age group 18-40 years presenting with the Symptoms of Anemia.
2. Hemoglobin percentage between 7gm%- 11.5gm%. (Mild-More than 10 less than 11.5 gm% and Moderate-7-10 gm% Anemia |
|
| ExclusionCriteria |
| Details |
1. Anemia due to Haemoglobinopathies.
2. Anemia secondary to other systemic disorders
3. Anaemia due to Traumatic injury, accidents, poisoning cases or any other terminal illness.
4. Anaemia due to congenital haemolytic disease. 5. Bone marrow depressive cases due to any drugs.
6. Suffering from other chronic diseases and on medication
7. Associated with Systemic diseases, pregnant and lactating woman |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing Moringa Oleifera mother tincture and the Constitutional Homoeopathic remedies in improving Hb% |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to elicit the effect of Moringa Oleifera mother tincture in improving Hb% |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [romagporwal1@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
A Comparative study to improve Hb% in Anemic women using Moringa Oleifera Mother Tincture Versus Constitutional Homoeopathic Remedies in rural areas in Belagavi.
Anaemia is a serious global public health problem that particularly affects young children and women. The prevalence of anaemia in 2019 in women aged 15-49 years is over half a billion. Ranking 17" in the Anaemia Mukt Bharat 2019-20 index, Karnataka has been tasked with reducing its Anemia burden’.
Anemia reduces the work capacity of individuals affecting their cognitive and physical development, with serious consequences for the economy and national development.
Homoeopathy has considerable success in the treatment and management of anaemia with constitutional and specific remedies. Moringa Oleifera possesses an affinity for oxygen and carries it to all parts of the body.
In Homoeopathy it is not well proved in treating anaemia. Hence this study aims to compare the efficacy of Moringa Oleifera over constitutional remedy in improving Hb% in anaemic women of rural areas of Belagavi.
This study aims
To assess the effectiveness of Moringa Oleifera mother tincture in improving Hb% in Anaemic women of rural areas of Belagavi.
To compare the efficacy of Moringa Oleifera with the constitutional remedy in improving Hb% in Anaemic women of rural areas of Belagavi.
Methodology In this comparative randomized clinical trial, Anaemic women of rural areas of Belagavi between the age group 18-40 years presenting with symptoms of anaemia and Hb% between 7gm% 11.5gm% will be selected through purposive sampling to investigate and compare the effectiveness of Moringa Oleifera mother tincture (group A) and the Constitutional Homoeopathic remedies (group B) in improving Hb%. Patients with Haemoglobinopathies, systemic disorders, traumatic injuries, terminal illness, congenital haemolytic disorders, bone marrow depressive cases, chronic systemic diseases, and pregnant and lactating women will be excluded. Group A will be administered 10 drops of Moringa Oleifera mother tincture in a glass of water twice a day before food and group B given constitutional Homoeopathic remedies. The remedies will be administered for 6 months with follow-up every month for both groups. Haemoglobin gram % will be assessed every month to estimate the before and after effects of the medication on the subjects. Haemoglobin will be estimated in the standardized auto analyzer. Data was collected. The collected data was analyzed with SPSS V.20 software and the Results were expressed as percentages using appropriate tables and figures.
Expected outcome:
This clinical study will help in comparing the effect of Moringa Oleifera mother tincture and the Constitutional Homoeopathic remedies in improving Hb% in Anaemic women of rural areas of Belagavi.
Also, this study will determine the scope of Homoeopathy in non-communicable disease |