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CTRI Number  CTRI/2023/04/052141 [Registered on: 28/04/2023] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic intervention for prevention of acute pain crises in Sickle Cell Anaemia 
Scientific Title of Study   An Ayurvedic intervention as an add on for prevention of acute pain crises in Sickle Cell Anaemia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr. Anuj Ramesh Varma 
Designation  Professor Dept. of Medicine 
Affiliation  Jawahar lal Nehru Medical College 
Address  Jawahar lal Nehru Medical College Sawangi – Meghe - 442001
Jawahar lal Nehru Medical College Sawangi – Meghe - 442001 Wardha
Wardha
MAHARASHTRA
442001
India 
Phone  9860500065  
Fax    
Email  anujvarma1985@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr MN Suryawanshi 
Designation  Assistant Director Incharge 
Affiliation  Regional Ayurveda Research Institute 
Address  Near Gharkul Parisar, NIT complex, nandanwan, Nagpur
Near Gharkul Parisar, NIT complex, nandanwan, Nagpur
Nagpur
MAHARASHTRA
440009
India 
Phone  9820284671  
Fax    
Email  vmsuryawanshi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr U R Sekhar Namburi 
Designation  Research Officer (Ayurveda) 
Affiliation  Regional Ayurveda Research Institute 
Address  Near Gharkul Parisar, NIT complex, nandanwan, Nagpur
Near Gharkul Parisar, NIT complex, nandanwan, Nagpur
Nagpur
MAHARASHTRA
440009
India 
Phone  8055595355  
Fax    
Email  shilpasekhar2k5@yahoo.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Jawahar Lal Nehru Bhartiya Chikitsa evam Homoepathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-58. (Ministry of AYUSH, Government of India)  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhukar Tikas  Shalinitai Meghe Hospital  Shalinitai Meghe Hospital, Wanadongri, Nagpur
Nagpur
MAHARASHTRA 		 9326029969

madhukartikas@gmail.com 
Dr S N Mahajan  Sickle Cell Unit, DMIMS, Wardha   Datta Meghe Institute of Medical Sciences, Wardha
Wardha
MAHARASHTRA 		 9765404099

mahajandr99@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee  Approved 
Ethics Committee  Approved 
Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D648||Other specified anemias. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dadimadi Ghrita, Reference: API, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Months, anupAna/sahapAna: Yes(details: Warm water), Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: AYUSH RP, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Months, anupAna/sahapAna: Yes(details: Warm water), Additional Information: -
3Comparator Arm (Non Ayurveda)-Standard care groupDrug - Hydroxyurea, Dose- 500mcg, Form – Capsule, Route- Oral, Time of Administration- Once in a day after meals, Vehicle (Anupana)- Water, Duration of therapy- As per the need (Guidelines issued by the Govt. of India, for prevention and management of Sickle Cell Anemia).
4Comparator Arm (Non Ayurveda)-Standard care groupDrug – Folic Acid, Dose- 400mcg, Form – Tablet, Route- Oral, Time of Administration- Once in a day after meals, Vehicle (Anupana)- Water, Duration of therapy- 8 Months.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  i)Must have sickle cell anemia confirmed by hemoglobin electrophorosis analysis with HbSS
ii) Participants must have the laboratory indices as defined below:
•Hemoglobin > 6 g/dL
•Platelets > 100,000/mcL
•Serum creatinine ≤ 1.5 mg/dL or upper normal limit
•INR ≤2.0, PTT ≤ 48 seconds
iii)Express willingness to adhere to the trial procedures and follow-up schedule
iv)Willing to give written informed consent
 
 
ExclusionCriteria 
Details  1. 5 or more hospitalizations for pain in the last 12 months
2. Receiving regularly scheduled transfusions more than once in every 3 months
3. History of a bleeding diathesis
4. History of clinically overt stroke within 2 years
5. Receiving chronic anti-coagulation or anti-platelet therapy
6. Have previously undergone a hematopoietic stem cell transplant or solid organ transplant
7. Red cell transfusion within 60 days
8. Patients who have a past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction and Stroke.
9. Symptomatic patients with clinical evidence of congestive cardiac failure.
10. Chronic liver disease or two times upper limit of normal level of ALT/AST
11. Patients having BP ≥ 160/100 mmhg.
12. Clinically significant infection episodes.
13. Unable to take oral medications or having malabsorption syndrome.
14. Active substance abuse.
15. Patients with concurrent Renal Dysfunction (defined as S. creatinine > 1.5 mg/dl.
16. Uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
17. Known cases of Hepatitis.
18. Patients with HBA1C - ≥ 8.
19. Known cases of HIV and AIDS.
20. Known cases of malignancy.
21. Patients of Hyperthyroidism.
22. Patient taking participation in any other clinical trial.
23. Women who are planning for conception / pregnant or lactating.
24. Any other condition which the P.I. thinks may jeopardize the study.
25. Heterozygous sickle cell trait (AS pattern).
26. Evidence of severe sickle-cell crisis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Reduction in incidence or frequency of sickle cell-related pain crises.  Baseline, 30th Day, 60th Day, 105th Day, 150th Day, 195th Day, 190th Day, 240th Day & follow-up after completion of 240th day between 3 to 6 months  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1. Absolute change from baseline in hemoglobin
2. Absolute change from baseline in lactate dehydrogenase
3. Decrease in frequency in episodes of Bleeding during the treatment period
4. Decrease in the frequency in number of RBC transfusions related to sickle cell-anaemia
5. Decrease in frequency of hospital admissions due to pain, during the treatment period
6. Improvement in hematological parameters (CBC, HbS, HbF, HbA).
7. Change in pain intensity measured by VAS
8. Duration of hospital stay
9. Incidence of Adverse events (with frequency & severity)
10. Need of analgesics/opioids use for pain.
11. Mean change in Indirect Bilirubin, Potassium & free haptoglobin & change in the levels of inflammatory marker CRP.
12. Assessing the Fatigueness (Modified Fatigue Impact Scale)
13. Assessing the quality of life through scale SF-12
14. Analysis of Ayurvedic Parameters [Prakruti] 		 Baseline, 30th Day, 60th Day, 105th Day, 150th Day, 195th Day, 190th Day, 240th Day & follow-up after completion of 240th day between 3 to 6 months 
 
Target Sample Size   Total Sample Size="1510"
Sample Size from India="1510" 
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 
Date of First Enrollment (India)   02/05/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response (Others) -  During study period data will be assessed by all investigators, IEC, DSMB, Funding authority, casualty assessment committee. After publication of the research it will be made available for all forum.

  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 (Others) -  Published protocols will be available at CCRAS, Head quarters and it will be made available prior permission from DG, CCRAS. Published articles will be available at respective journal website.

  6. For how long will this data be available start date provided 03-06-2027 and end date provided 03-06-2032?
    Response (Others) -  As per rules and regulations of CCRAS

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  

Sickle cell anemia is one of a group of disorders known as sickle cell disease. It is a hereditary defect confined to RBC where basic defect in the structure of Hemoglobin molecule. These cells acquire sickle like shape of RBCs and in hypoxic condition, causes early destruction leads to Anemia. The main clinical features are joint pain, jaundice and Anaemia. SCD is not curable by medicine or surgery. Presently Stem cell Therapy and Gene therapy are available which are very expensive. The drugs like Hydroxyurea are useful to reduce severity of symptoms but not affordable to people. The only possible symptomatic treatment is folic Acid, NSAIDs Soda-bicarbonate. At this scenario it was decided to study this disorder in Ayurvedic perspective and to develop a protocol of Ayurvedic management. The study primarily included 8 months intervention with assessment at scheduled intervals. Further to assess sustained effectiveness of the Ayurvedic intervention, a follow-up is added to be conducted for willing participants between 3 to 6 months after Day 240. This study is intended to evaluate the therapeutic efficacy of Ayurvedic intervention, as an add on to standard medical care, in the prevention of acute pain crises in sickle cell anemia with its sustained effectiveness over an extended follow-up period.


 
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