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CTRI Number  CTRI/2021/11/038224 [Registered on: 24/11/2021] Trial Registered Prospectively
Last Modified On: 24/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Yoga]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Impact of traditional ayurvedic preparation vs yoga vs placebo on Iron Deficiency Anemia. 
Scientific Title of Study   Study to evaluate the efficacy of Ayurvedic Intervention with Yoga and Placebo as a treatment regime for Iron Deficiency Anemia: an open label, three arm, randomised control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anurag Sharma 
Designation  Ayurvedic Practitioner, Head of Panchkarma  
Affiliation  Patanjali Yog Gram 
Address  Niramayam-Yoggram Village Aurangabad, Near SIDCUL Roshnabad, Haridwar, Uttarakhand-249405, India
Panchkarma Department No. 2 Niramayam-Yoggram Village Aurangabad, Near SIDCUL Roshnabad, Haridwar, Uttarakhand-249405, India
Hardwar
UTTARANCHAL
249405
India 
Phone    
Fax    
Email  clinical.investigator@prft.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Anurag Sharma 
Designation  Ayurvedic Practitioner, Head of Panchkarma  
Affiliation  Patanjali Yog Gram 
Address  Panchkarma Department No. 2 Niramayam-Yoggram Village Aurangabad, Near SIDCUL Roshnabad, Haridwar, Uttarakhand-249405, India
Panchkarma Department No. 2 Niramayam-Yoggram Village Aurangabad, Near SIDCUL Roshnabad, Haridwar, Uttarakhand-249405, India
Hardwar
UTTARANCHAL
249405
India 
Phone    
Fax    
Email  clinical.investigator@prft.in  
 
Details of Contact Person
Public Query  
Name  Ritu Tyagi 
Designation  Research Scholar 
Affiliation  Department of Allied and Applied Sciences 
Address  University of Patanjali Patanjali Yog Peeth, Roorkee Haridwar Road, Haridwar, Uttarakhand 249405

Hardwar
UTTARANCHAL
249405
India 
Phone    
Fax    
Email  reetutyagi97@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Research Institute governed by Patanjali Research Foundation Trust 
 
Primary Sponsor  
Name  Patanjali Research Institute governed by Patanjali Research Foundation Trust 
Address  Patanjali Research Institute Near Patanjali Yogpeeth Phase 1, NH 58 Haridwar, Uttarakhand 249405 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anurag Varshney  Patanjali Yog Gram   Panchakarma Department Niramayam Yog Gram Village Aurangabad, Near Sidcul Roshnabad, Haridwar, Uttarakhand 249405, India
Hardwar
UTTARANCHAL 		 7302254792

clinical.investigator@prft.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D50||Iron deficiency anemia. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Patanjali Nutrela Iron Complex Naturals, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 350(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information:
2Comparator Arm (Non Ayurveda)-Yogic InterventionPostures: Supine position-1, Standing position-1, Prone position- 1, Sitting position-1 , Forward bending-1, 45 minutes, Morning, Once in a day
3Comparator Arm (Non Ayurveda)-Placebo
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adult male and non-pregnant female population having mild or moderate Iron Deficiency anemia (IDA) caused by different aetiology such as abnormal uterine bleeding and other conditions leading to significant blood loss prior to trial enrolment.
2. Hemoglobin ranges
Non pregnant women mild: 110 to 119 g per l, moderate: 80 to 109 g per l.
Men, 15 years and above mild: 110 to 129 g per l, moderate: 80 to 109g per l.
3. Transferrin saturation less than 20%
4. S-ferritin less than 30 µg per l.
5. Willingness to participate and sign the informed consent form.
 
 
ExclusionCriteria 
Details  1.Anemia predominantly caused by factors other than Iron Deficiency Anemia e.g. anemia with untreated vitamin B12 or folate deficiency, sickle cell anemia, thalassemia minor.
2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
3. Pregnant or lactating women.
4. Known hypersensitivity to any excipients in the investigational drug products.
5. Erythropoietin treatment within 8 weeks prior to the screening visit.
6. Patients planning surgery within the trial phase or received a blood transfusion a week prior to the screening visit.
7. Any other medical condition that, in the opinion of investigator, make the patient incompetent to participate in the trial or place the patient at potential risk, e.g. any chronic comorbidity.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in laboratory parameters compared to baseline after 3 months of Ayurvedic intervention.
Change in laboratory parameter compared to baseline after 3 months of yogic practices.
 		 Baseline, Day 90
 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in sleep quality, quality of life, anxiety levels, fatigue, mood states and pain.
Treatment satisfaction and adherence.
 		 Baseline, Day 45, Day 90 
 
Target Sample Size   Total Sample Size="123"
Sample Size from India="123" 
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)   15/12/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study is a three-arm, open-label, parallel-group and placebo-controlled trial. The trial will randomize 123 participants in the ratio of 1:1:1 of 18 yrs. and above equally to 1st arm: Ayurvedic intervention, 2nd arm: Yogic practices, 3rd arm: Placebo. Participants will receive interventions for 3 months.

The primary outcome includes improvement in laboratory parameters after 3 months of interventions. Secondary outcomes include assessment of treatment satisfaction, patient’s compliance, sleep quality, quality of life, mood states, pain and anxiety levels. 
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