| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D570||Hb-SS disease with crisis. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator 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. |