| CTRI Number |
CTRI/2024/11/076705 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Ayurvedic study for prevention of Iron Deficiency Anemia in Mawpat and Mylliem Block of Meghalaya |
|
Scientific Title of Study
|
Promoting the Ayurvedic intervention for Iron Deficiency Anemia (IDA) among tribal females (18 to 45 years of age) in Mawpat and Mylliem Block of East Khasi Hills District of Meghalaya |
| 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 Manoj Nesari |
| Designation |
Director |
| Affiliation |
Northeastern Institute of Ayurveda and Homeopathy |
| Address |
Room No 1 Administrative Block
Northeastern Institute of Ayurveda and Homeopathy Shillong
Mawdiangdiang Meghalaya 793018
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
03642538134 |
| Fax |
|
| Email |
dir-neiah@nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Soni |
| Designation |
Assistant Professor |
| Affiliation |
Northeastern Institute of Ayurveda and Homeopathy |
| Address |
Room NO 36 College of Ayurveda,
Northeastern Institute of Ayurveda and Homeopathy Shillong
Mawdiangdiang Meghalaya 793018
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
9450926977 |
| Fax |
|
| Email |
gauravsonilko@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Soni |
| Designation |
Assistant professor |
| Affiliation |
North Eastern Institute of Ayurveda and Homeopathy |
| Address |
Room No 36, College of Ayurveda Northeastern Institute of Ayurveda and Homeopathy Shillong
Mawdiangdiang Meghalaya 793018
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
9450926977 |
| Fax |
|
| Email |
gauravsonilko@gmail.com |
|
|
Source of Monetary or Material Support
|
| MINISTRY OF AYUSH
Ayush Bhawan B Block GPO Complex INA New Delhi 110023 |
|
|
Primary Sponsor
|
| Name |
Ministry of Ayush |
| Address |
Ayush Bhawan B Block GPO Complex INA New Delhi 110023 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CCRAS |
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Soni |
North Eastern Institute of Ayurveda and Homoeopathy |
Room No-64 College of Ayurveda NEIAH Mawdiangdiang Shillong
East Khasi Hills
MEGHALAYA |
9450926977
gauravsonilko@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC North Eastern Institute of Ayurveda and Homoeopathy (NEIAH), MAwdiangdiang, Shillong-793018 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krimimudgar Ras , Reference: AFI part 1:20:10.page 260, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: -(2) Medicine Name: Purnarva Mandoor , Reference: AFI part 1:19:1.page 251, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: -(3) Medicine Name: Draksha Aveleha , Reference: AFI part 1:3:15.page 40, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Hemoglobin level between 8gm to 10.9gm/dl.
Willing to provide informed written consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
Recent history of severe acute or chronic blood loss from the gastrointestinal or other sources in the form of Haematemesis, Melena, Bleeding Piles, Hemoptysis, Menorrhagia, malaria, surgery & traumas.
Known case of pernicious Anemia, anemia due to chronic disease and medications, Thalassemia, sickle cell anemia, Bone marrow suppression (aplastic anemia) mechanical heart valves, hemolytic uremic syndrome (HUS) or Hypothyroidism.
Patients already on iron supplements at present or during the last 3 months.
Known case of disease conditions with intestinal malabsorption, alcohol use disorder (AUD), (CAGE score more than 2).
Known case of other major co-morbidities like chronic cardiac or pulmonary diseases & malignancy.
Known cases with concurrent serious Hepatic Dysfunction or Renal Dysfunction.
Patients on prolonged (more than 6 weeks) medication (steroids, immunosuppressants, disease modifying agents, chemotherapy etc.) for any chronic disease that may have an influence on the outcome of the study
Pregnant women or lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Awareness about the anaemia, screening of haemoglobin level in females of age 18 to 45 years in said area, evaluation of the effectiveness of Ayurveda interventions in the prevention and treatment of anemia on a mass scale, decrease in mortality rate due to IDA and overall well being of female. |
ï¶ Twice Post-intervention follow-up after completion of medicine and tests, after 15 days and 30 days via telephone. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of IDA among
reproductive age women of said areas.
To determine association of IDA with its
pre-disposing factors.
To associate IDA with food consumption pattern
and BMI.
To evaluate the knowledge about anaemia and
its consequences among respondents.
To create awareness among rural women
through camp, lectures, seminars & videos.
(Sensitization in the selected area) |
180 days |
|
|
Target Sample Size
|
Total Sample Size="3750"
Sample Size from India="3750"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
1. Firstly recruitment of manpower for study and purchase of said equipment, reagents, etc. will be made. 2. Awareness training and workshop programs will be organized for health workers as well as locals regarding the importance of dietary and hygiene habits in personal as well as community health status. Distribution of IEC material will be circulated among the selected area. 3. Further screening for Anemia will be done by questionnaire among the female population of Mawpat and Mylliem Block of East Khasi Hills district of Meghalaya by organizing the awareness cum screening camps by the recruited mobile camp team. (30,000 females). 4. On the basis of questionnaire, those females who report symptoms of anaemia and will give consent will be screened for Haemoglobin percentage (Hb %) by digital hemoglobinometer. (15,000 females). 5. On the basis of Hb% those consented females who are going to fall under the range of moderate anaemia (more than 8gm/dl less than10.9 gm/dl) will undergo further lab investigation for CBC. (75,00 females) 6. On the basis of MCHC (less than 30%) & MCV (less than 87 cubic micron) value & Hb level (more than 8gm/dl less than 10.9 gm/dl) the consented females will undergo the medication. (3750 females) 7. For initial 7 days females will undergo deworming by Krimimudgar Ras as per specified doses. 8. Further for 90 days females will be given Purnarva Mandoor and Drakha Aveleha in specified doses. 9. At the end of 90 days the females have to undergo post lab test for CBC. (3750 females) 10. Among the selected 3750 females for treatment 1500 will be selected randomly for pre & post serum ferritin (Day 0 & Day 97). 11. Two-three camps in each block in a month planned by dividing the total area in specified subgroups making it stratified sample survey study. 12. Nutritional assessment will be made on the 24-hour dietary recall method and quality of life assessment will be made via the WHOQOL-BREF questionnaire. 13. All the data collected will be statistically analyzed and publications will be made. 14. Further a comparative analysis could be undertaken between the current study & the effect of modern medicines within same inclusion & exclusion criterias data available or published online or provided by the concern authority. |