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CTRI Number  CTRI/2022/06/043247 [Registered on: 14/06/2022] Trial Registered Prospectively
Last Modified On: 06/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of herbomineral Formulation T-AYU-HM Premium in sickle cell anemia patients  
Scientific Title of Study   Clinical Assessment of antisickling herbomineral formulation T-AYU-HM Premium on sickle cell anemia at Dhanvantari clinic OPD patients: A prospective study 
Trial Acronym  SCA-AHP-F 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atul Desai 
Designation  Principle Investigator 
Affiliation  Dhanvantari Clinic, Ayurveda Healthcare and Research centre 
Address  Dhanvantari clinic, Ayurveda healthcare and research center, Vyara-Gujarat
Shreeji Desai market, Near old bus stand, Vyara
Surat
GUJARAT
394650
India 
Phone  9879031621  
Fax    
Email  dratuldesai@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Atul Desai 
Designation  Principle Investigator 
Affiliation  Dhanvantari Clinic, Ayurveda Healthcare and Research centre 
Address  Dhanvantari clinic, Ayurveda healthcare and research center, Vyara-Gujarat
Shreeji Desai market, Near old bus stand, Vyara
Surat
GUJARAT
394650
India 
Phone  9879031621  
Fax    
Email  dratuldesai@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Atul Desai 
Designation  Principle Investigator 
Affiliation  Dhanvantari Clinic, Ayurveda Healthcare and Research centre 
Address  Dhanvantari clinic, Ayurveda healthcare and research center, Vyara-Gujarat
Shreeji Desai market, Near old bus stand, Vyara
Surat
GUJARAT
394650
India 
Phone  9879031621  
Fax    
Email  dratuldesai@rediffmail.com  
 
Source of Monetary or Material Support  
ATBU Harita Pharmaceuticals Pvt ltd. 110, Shreeji Desai Market, Sardar Chowk Vyara - 394650, Gujarat, India for monetary Support Dhanvantari Clinic, Ayurveda Health Care and Research Center 301, Shreeji Desai market, Sardar Chowk Vyara-394650, Gujarat. India for Material support  
 
Primary Sponsor  
Name  Dhanvantari Clinic Ayurveda Health Care and Research Center 
Address  Shreeji Desai Market, Vyara-394650, Gujarat. India 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
ATBU Harita Pharmaceuticals Pvt ltd  Vyara,Gujarat,India. Email: atbuharita@gmail.com 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atul Desai  Dhanvantari Clinic  Dhanvantari Clinic, Ayurveda Health Care and Research Center
Surat
GUJARAT 
9879031621

dratuldesai@rediffmail.com 
Dr Kavita Desai  Dhanvantari clinic   103 Parekh Chembers Surti Jakat Naka Bardoli Gujarat India
Surat
GUJARAT 
9726006511

drkavitadesai@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Divyajyoti Trust Tejas Eye Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D570||Hb-SS disease with crisis. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: T-AYU-HM Premium, Reference: Preclinical and Clinical, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -
2Comparator Arm (Non Ayurveda)-Folic acid Folic Acid , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 5(mg), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: water), Additional Information:
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Patients between the ages above 07 to 55 years from both sexes from sickle hemoglobin.
2.Written informed parental/guardian consent and participant assent (where applicable) has been obtained per requirements, consistent with ICH guidelines.
3.Participant/Guardians must agree to adhere to Treatment guidelines.
4.Willingness to sign an informed written consent and comply with visit schedules.
5.Participants confirms of HBSS through HPLC
6. Participant who are confirmed Sickle cell anemia patients with positive microscopic sickle cell test, sickle cell solubility test.
7.Participants exhibit no other existing comorbidities
8.Participants having Negative Hepatitis B test.
9.Hemoglobin ≥ 6.0 and ≤ 11.0 g/dL during screening
10.Participants/Guardians agree to provide regular feedback and questionnaire during schedule visit
11. Participants having veg/non veg diet
12.Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
13.Participant needs to be admitted to the ambulatory site for treatment of VOC requiring pain medication 
 
ExclusionCriteria 
Details  1.Participants not willing to participate
2.Participants having renal impairment
3.Participants not willing to visit clinic for schedule follow up.
4.Any other condition which the Principle Investigator thinks may jeopardize the study
5.Pregnant / lactating woman
6.Participants with unresolved infections or existing comorbidities.
7.Participants on any other treatment within 07 days of the first dose of study drug or who have not recovered from the side effects of such therapy
8.Participants have history of hospitalized treatment or blood transfusion before 15 days.
9.Participants taking any other then investigational drug in last 7 days
10.Participants who are allergic/Hypersensitivity reactions to herbal supplements and medications.
11.Participants who are unable to take and absorb oral medications, unable to swallow tablets.
12.Participants who are not able to understand and to comply with study instructions and requirements.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Mean Change in Level of Red blood corpuscles in participants.
2. Mean Change in the Level of Types of Hemoglobin in participants.
3.Mean Change in various blood counts in participants.  
1.Mean Change in Level of Red blood corpuscles in participants Measured by Laboratory analysis day 0, 15th, 120, and 180 day of schedule visit examination
2. Mean Change in the Level of Types of Hemoglobin in participants Measured by HPLC for HbS,HbF, and HbA on 0 day, and 180 day of schedule visit examination.
3.Mean Change in various blood counts in participants measured by Complete blood counts analysis day 0, 15th, 120, and 180 day of schedule visit examination  
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean change in major and minor complaints in participants
2. Extent of reduction in pain score during ambulatory visit as assessed by the participant on a pain scale
3.Mean change in quality of life in participants  
1. Measure by Score and follow up visit examination
2. Measure by Pain scale and physical observation during schedule follow up visit examination
3. measure by Physical, laboratory values and quality of life questionnaire on scheduled visit examination  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   19/06/2022 
Date of Study Completion (India) 28/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/05/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Desai A, Desai K, Desai H, Desai C. Randomized, Multicentric Parallel-Group Clinical Trial of the Herbo-Mineral Formulation T-AYU-HM Premium in Patients with Sickle Cell Anemia: A Prospective Study. J Young Pharm. 2025;17(2):365-75. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Sickle cell anemia a type of autosomal recessive disorder which requires treatment to be tolerated well throughout the life, safe and effective too. Preventing complications can be vital in preventing mortality in sickle cell patients. Sickling can be produced by a variety of factors, including hemolysis, cellular hyper-adhesion, oxidative stress, sterile inflammation, endothelial dysfunction, haemostatic activation, and blood hyper viscosity. During a sickling, these factors can cause sickle cell disease patients to become hypercoagulable. As a result, preventing this has become critical in the treatment of sickle cell patients. The formulation has documented anti-sickling activity. The previous studies have already suggested that T-AYU-HM Premium prevents lysis and there by sickling induced complications in sickle cell anemia. Therefore the primary objective of the study is to assess the effectiveness of T-AYU-HM Premium on red blood corpuscles and types of hemoglobin. The sickling induced activation of neutrophils and platelets during hypercoagulation state are might be the reason for causing vasoocclusive pain full crisis in sickle cell patients. Therefore, effectiveness of formulations preventing lysis and sickling can be reflected through the observation of other blood cell parameters in sickle cell anemia patients. Improvement in clinical parameters can be observed physically and through laboratory parameters to confer the effectiveness of formulation in sickle cell anemia patients. Acute pain in patients with sickle cell disease is caused by ischemic tissue injury resulting from the occlusion of microvascular beds by sickle erythrocytes during an acute crisis. Therefore the study emphasizes to evaluate changes in major and minor complains and impact of the treatment on pain and health related quality of life in patients receiving treatment.

 
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