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CTRI Number  CTRI/2024/10/075128 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurveda medicines for Anaemia prevention in adolescent girls of five Mission Utkarsh districts 
Scientific Title of Study   Anaemia control among adolescent girls through Ayurveda interventions in the five districts under Mission Utkarsh 
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 Sarada Ota 
Designation  Assistant Director (Ay), CARI, Bhubaneshwar 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Central Ayurveda Research Institute Bharatpur Assistant Director (Ay), Technical department, Research division Room No 53 Near Kalinga Studio Bhubaneshwar Khordha Odisha

Khordha
ORISSA
751029
India 
Phone  9810425662  
Fax    
Email  sarada_ota@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarada Ota 
Designation  Assistant Director (Ay), CARI, Bhubaneshwar 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Central Ayurveda Research Institute Bharatpur Assistant Director (Ay), Technical department, Research division Room No 53 Near Kalinga Studio Bhubaneshwar Khordha Odisha

Khordha
ORISSA
751029
India 
Phone  9810425662  
Fax    
Email  sarada_ota@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sarada Ota 
Designation  Assistant Director (Ay), CARI, Bhubaneshwar 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Central Ayurveda Research Institute Bharatpur Assistant Director (Ay), Technical department, Research division Room No 53 Near Kalinga Studio Bhubaneshwar Khordha Odisha

Khordha
ORISSA
751029
India 
Phone  9810425662  
Fax    
Email  sarada_ota@yahoo.com  
 
Source of Monetary or Material Support  
Jointly funded by the Ministry of Ayush GPO Complex, B Block, Barapullah Rd, INA Colony, New Delhi, Delhi 110023, India and Ministry of Women and Child Development(WCD), Shastri Bhawan, Dr. Rajendra Prasad Road, New Delhi 110001, India 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  61-65 Institutional Area Opp D Block Janakpuri New Delhi Pin- 110058  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meenakshi Pandey  District women and child development office, Bastar, Chattisgarh  District Development Officer Joint District office W.C.D., Jagdalpur Division, Bastar, Chattisgarh pin-494001.
Bastar
CHHATTISGARH 		 9984549998

drmeenakshipathak@gmail.com 
Dr Jeuti Rani Das  District women and child development office, Dhubri, Assam  The District Social Welfare, office, Raja Ram Mohan rai, Road, Ward No.- 2, District-Dhubri, pin-783301, Assam.
Dhubri
ASSAM 		 9509192744

djeutirani@yahoo.in 
Dr M N Suryawanshi  District women and child development office, Gadchiroli, Maharashtra  WCD office, Police Quarters, Gadchiroli, Maharashtra, pin-442605
Gadchiroli
MAHARASHTRA 		 8329875011

amhri-nagpur@gov.in 
Dr Sarada Ota  District women and child development office, West Singhbhum, Jharkhand  Collector office, Chaibasa, West Singhbhum, Jharkhand-833201
Pashchimi Singhbhum
JHARKHAND 		 9810425662

sarada_ota@yahoo.com 
Dr Brahm Dutt Sharma  District women and child development, Dholpur, Rajasthan   District Women and child development office, near Zila Parishad, Bari Road, Dholpur, Rajasthan, pin- 328001
Dhaulpur
RAJASTHAN 		 9887859095

dr.bdsharma@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Central Ayurveda Research Institute Guwahati Institutional Ethical Committee and NOC Dhubri  Approved 
Central Council for Research in Ayurvedic Sciences Central Ethics Committee & NOC West Singhbhum  Approved 
Indian Institute of Public Health Institutional ethics Committee (IEC)  Approved 
Institutional Ethics Committee Govt. Ayurved College Raipur Chhattisgarh NOC Bastar  Approved 
Institutional Ethics Committee National Institute of Ayurveda Jaipur NOC Dholpur  Approved 
Regional Ayurveda Research Institute Nagpur Certificate of Ethical Clearance Institutional Ethics Committee and NOC Gadchiroli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D520||Dietary folate deficiency anemia. Ayurveda Condition: PANDUROGAH, (2) ICD-10 Condition:D50||Iron deficiency anemia. Ayurveda Condition: PANDUROGAH, (3) ICD-10 Condition:D539||Nutritional anemia, unspecified. Ayurveda Condition: PANDUROGAH, (4) ICD-10 Condition:D513||Other dietary vitamin B12 deficiency anemia. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Krimimudgar Rasa, Reference: AFI Part 1 20:10, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Drakshavaleha, Reference: AFI Part 2 Vol 2, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
(3) Medicine Name: Punarnavadi Mandoora, Reference: API Part 2, Vol 3, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  18.00 Year(s)
Gender  Female 
Details  Girls between 14-18 years of age and willing to take the Ayurveda interventions for 3 months along with the ongoing conventional anemia prevention measures
 
 
ExclusionCriteria 
Details  1) Girls who are married/pregnant
2) Known cases of any Hemoglobinopathies, bleeding disorders, serious systemic illnesses, Diabetes mellitus, malignancies, and having family history of hemoglobinopathies and history of blood transfusion in last 6 months
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The impact of the Ayurveda interventions on the status of Anemia in the sample selected from the population will be assessed through –
change in hemoglobin level (venous), ferretin level, score of fatigue assessment scale (FACIT) and score of appetite assessment scale (SNAQ), before and after the intervention for three months
(This will be independently assessed by the Indian Institute of Public Health, Delhi and the proposal is approved by their IEC)
 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1) Change in hemoglobin (capillary) assessed through strip based digital hemoglobinometer, incidence of fatigue & status of appetite of the population taking Ayurveda interventions
2) Proportion of the beneficiaries showing thinness assessed by body mass index (BMI) for age (as per the 2007 WHO Growth Reference), after the intervention period
3) Proportion of the population showing ≥70% of adherence to the Ayurveda interventions (probable factors associated with lack of adherence to the Ayurveda interventions shall be explored proportion of non-adherence is more than 50%)
4) Assessment of various factors of actual internal and external settings through evaluation of the structured interviews of the representatives from various stake holders in implementing this project.
 		 12 weeks 
 
Target Sample Size   Total Sample Size="1505"
Sample Size from India="1505" 
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)   25/10/2024 
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="0"
Months="8"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dg-ccras@nic.in].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 31-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This project includes two components - 1) Distribution of Ayurveda medicine to all the adolescent girls (age 14-18 years) registered in the Poshan scheme of Ministry of Women and Child Development, Government of India, in the Anganwadi Centres of the five districts identified under Mission Utkarsh. Total target number of beneficiaries (population) for distribution of Ayurveda medicines is 94,635 girls. 2) However, the effect of the Ayurveda interventions in prevention on the parameters of anemia will be assessed independently by Indian Institute for Public Health, Delhi in a sample of 1505 participants among the said population in the five districts.

The Ayurveda interventions viz., Krimimudgar Rasa (7 days), Drakshavaleha (90 days) and Punarnavadi Mandur (90 days), with known effectiveness and safety will be given as adjunct to the standard ongoing measures for Anaemia prevention, to the adolescent girls (of age 14 to 18 years), registered in the Poshan Scheme at the Anganwadi centres in the identified districts. Information education and communication will be done regarding appropriate nutrition, the importance of treatment adherence to the conventional regimen of Iron-Folic Acid and, the Ayurveda interventions in this project and, other healthy lifestyle practices will also be given to all the beneficiaries. 

This project is a joint venture of Ministry of Ayush and Ministry of Women and Child Development and is implemented by CCRAS. This is a multi-centre project which will be executed by five Ayush institutes and the outcome will be assessed in all the five districts by Investigators of IIPH-D. 

 
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