| CTRI Number |
CTRI/2025/06/088988 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Public Health Initiative to study the role of Ayurveda in improving Hemoglobin level in women of reproductive age in Chengalpattu district of Tamilnadu |
|
Scientific Title of Study
|
A community based study to assess the role of Ayurvedic interventions and lifestyle advocacy on Iron Deficiency Anemia in women of reproductive age in Chengalpattu district of Tamilnadu |
| 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 S Asha |
| Designation |
Research Officer |
| Affiliation |
CCRAS-Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute |
| Address |
Room No 8, Second Floor,CCRAS-Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute,VHS Hospital Campus, TTTI Post, Taramani, Chennai
Chennai
TAMIL NADU
600113
India |
| Phone |
9895192067 |
| Fax |
|
| Email |
dr.ashas2324@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Asha |
| Designation |
Research Officer |
| Affiliation |
CCRAS-Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute |
| Address |
Room No 8, Second Floor,CCRAS-Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute,VHS Hospital Campus, TTTI Post, Taramani, Chennai
Chennai
TAMIL NADU
600113
India |
| Phone |
9895192067 |
| Fax |
|
| Email |
dr.ashas2324@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Asha |
| Designation |
Research Officer |
| Affiliation |
CCRAS-Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute |
| Address |
Room No 8, Second Floor,CCRAS-Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute,VHS Hospital Campus, TTTI Post, Taramani, Chennai
Chennai
TAMIL NADU
600113
India |
| Phone |
9895192067 |
| Fax |
|
| Email |
dr.ashas2324@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurswasthya Yojana Scheme, Ministry of Ayush, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi, India
PIN- 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Asha |
CCRAS-Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute, Chennai |
Room No 8, 2nd Floor, CCRAS-Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute, VHS Hospital Campus, TTTI Post, Taramani,Chennai
Chennai
TAMIL NADU |
9895192067
dr.ashas2324@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of CCRAS-Dr. Achanta Lakshmipathi Regional Ayurveda Research Institute,Chennai |
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 | Lifestyle | - | - | Dinacarya: Nil, Ritucarya: Nil, Acara Rasayana:Nil, Other:Nil, Pathya/Apathya:yes, Pathya:Ayurveda Based dietary practices. Diet for improving Hemoglobin level in reproductive age women. including beet root, green leafy vegetables, til, red rice, red meat, egg, cashew, sardine, green peas etc., Apathya:Diet hindering with iron absorption in body like mustard leaves, maida, urad dal, excess of dairy products, taking tea/coffee immediately after diet, fried and baked foods etc. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnavadi Mandura, Reference: Caraka Samhita, Chikitsa Sthana, Chapter16, Sloka 93-95, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: NIL(2) Medicine Name: Dadimadi Ghrita, Reference: Ashtanga Hrudayam, Chikitsa Sthana, Chapter 16, Sloka 2-4, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Non-pregnant non-lactating women of reproductive age(15 to 49years),Hb greater than or equal to 8 gm percentage and less than 12 gm percentage,intend to remain in the study site for the next 6 months atleast, willingness to sign the informed consent form(Written assent in participants below 18 years of age) and to participate in the study related activities such as adherence to lifestyle advocacy,study intervention, logging in compliance log, etc.
|
|
| ExclusionCriteria |
| Details |
Severe anemia(less than 8gm percentage) warranting immediate referral and care, history of diagnosis of other types of anemia, Women with menstrual irregularities such as menorrhagia, irregular menstrual cycles, cycle duration less than 24 days, History of any chronic or other medical condition (e.g. IBS, IBD, malignancy) requiring frequent medical attention or potentially interfering with nutritional status, malnutrition warranting medical attention, Obesity (BMI greater than or equal to 29.9),any chronic or acute illness that require intake of any other medications other than oral hypoglycemic agents or anti-hypertensive, any other condition that, as per the PI would adversely affect participation in the study or the outcome of the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Hemoglobin level |
To be assessed during baseline,90thday and 180th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in the other blood indices such as RBC Count, MCV, MCHC, and PCV
2.Change in Serum Ferritin level
3.Medication adherence and compliance to lifestyle advocacy
4.Documentation of demographic characteristics and severity of anemia through pre-designed questionnaire to assess the association between both
|
1. To be assessed during baseline,90thday and 180th Day
2. To be assessed during baseline,90thday and 180th Day
3. To be assessed during 30th, 60th and 90th day
4.To be assessed during Baseline |
|
|
Target Sample Size
|
Total Sample Size="1120"
Sample Size from India="1120"
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)
|
07/07/2025 |
| 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 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
|
The present study is conducted to assess the role of Ayurvedic Interventions and Lifestyle advocacy on Iron Deficiency anemia in women of reproductive age in a selected district in Tamil Nadu. It is a single arm study in which willing reproductive-age women (15 to 49 years age) will be enrolled. It will be carried out in 1120 participants and the total duration of study will be 3 years. Ayurvedic Medicines viz, Punarnavadi Mandura and Dadimadi Ghritha and lifestyle advocacy will be adviced to follow for 90 days. The primary outcome will be change in Hemoglobin level which will be assessed during baseline, 90th day and 180th day. Secondary outcomes include change in blood indices such as RBC Count, MCV, MCHC, and PCV, Change in Serum ferritin, Medication adherence and compliance to lifestyle advocacy and documentation
of demographic characteristics and severity of
anemia
through pre-designed questionnaire to assess the association between both. |