| CTRI Number |
CTRI/2025/05/087392 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of the Safety, Effectiveness, and Benefits of Tapyadi Loha in Treating Sickle Cell Anemia |
|
Scientific Title of Study
|
To determine the anti-sickling and antioxidant activity of tapyadi loha through in vitro study and to evaluate the safety, efficacy and tolerability of tapyadi loha in sickle cell anemia through pilot clinical study.
|
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suchita Ware |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute Of Ayurved And Research |
| Address |
Department Of Kayachikitsa 3rd Floor Room no 406 Parul Institute Of Ayurved And Research Parul University P.O Limda Vadodara Gujrat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9881576474 |
| Fax |
|
| Email |
suchitawr24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurved And Research |
| Address |
Department Of Kayachikitsa 3rd Floor Room no 406 Parul Institute Of Ayurved And Research Parul University P.O Limda Vadodara Gujrat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9096082950 |
| Fax |
|
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suchita Ware |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute Of Ayurved And Research |
| Address |
Department Of Kayachikitsa 3rd Floor Room no 406 Parul Institute Of Ayurved And Research Parul University P.O Limda Vadodara Gujrat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9881576474 |
| Fax |
|
| Email |
suchitawr24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kayachikitsa 3rd Floor Room no 406 Parul Institute Of Ayurved And Research Parul University P.O Limda Vadodara Gujrat India 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Suchita Ware |
| Address |
Department Of Kayachikitsa 3rd Floor Room no 406 Parul Institute Of Ayurved And Research Parul University P.O Limda Vadodara Gujrat India 391760 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suchita Ware |
Khemdas Hospital |
OPD No. 08 Ground Floor,Department of Kayachikitsa, Parul Institute of Ayurveda and Research Parul University, Ishwarpura, Vadodara, Gujarat, India, Pincode-391760
Vadodara
GUJARAT |
9881576474
suchitawr24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, IEC-PIARHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D571||Sickle-cell disease without crisis. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tapyadi Loha, Reference: Charaka Chikitsa 16/78-79, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -if the patient is taking Hydroxyurea or Folic Acid those will be continued |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Non pregnant, non lactating woman.
2. Diagnosed case of sickle cell anemia
3. Willing to give written informed consent for participation in the trial as well as willing and able to comply with study visit schedule and other protocol requirements.
|
|
| ExclusionCriteria |
| Details |
1. K/C/O HIV antibody, HBsAg or HCV antibody
2. Alcohol or any drug dependence within past one year.
3. Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening
4. Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening
5. Patients having acute phase of crisis and with various complication such as stroke, renal failure, spleen infraction, transfusional iron overload and Recently blood transfused individuals.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Maintenance of Hb levels
2.Frequency-duration- intensity of crises
3.Requirement of in-patient hospitalization
4.Number of days of hospitalization
5.Requirement of intensive care
6.Quality of life.
|
1.Maintenance of Hb levels - 0th Day 30th and 60th Day 90th Day
2.Frequency-duration- intensity of crises - 0th Day 30th and 60th Day 90th Day
3.Requirement of in-patient hospitalization - 0th Day 30th and 60th Day 90th Day
4.Number of days of hospitalization - 0th Day 30th and 60th Day 90th Day
5.Requirement of intensive care - 0th Day 30th and 60th Day 90th Day
6.Quality of life- 0th Day 30th and 60th Day 90th Day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) To determine the safety and tolerability of Tapyadi Loha in Sickle cell anemia on the basis of occurrence/ severity/ requirement of medicine/ causality assessment of adverse event. |
1) To determine the safety and tolerability of Tapyadi Loha in Sickle cell anemia on the basis of occurrence/ severity/ requirement of medicine/ causality assessment of adverse event. -0th Day
-30th and 60th Day
-90th Day |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 2 |
|
Date of First Enrollment (India)
|
26/05/2025 |
| 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)
|
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 - NO
|
|
Brief Summary
|
Sickle Cell Anemia (SCA) is a hereditary blood disorder prevalent in India’s tribal populations, with the country holding the highest number of sickle gene carriers globally. Despite treatment strategies involving blood transfusions, hydroxyurea, and stem cell transplantation, challenges like high mortality rates, affordability, and limited access persist. In 2006, Gujarat implemented a program to address SCA. Hydroxyurea, which reduces sickling of red blood cells, and blood transfusions are common treatments, though stem cell transplants remain cost-prohibitive for many. The study aimed to explore the efficacy of Ayurvedic treatments, particularly Tapyadi Loha, in managing SCA by bridging the gap between Ayurveda and Western medicine. The research hypothesizes that Tapyadi Loha possesses anti-sickling and antioxidant properties, offering an alternative or complement to conventional treatments. Phase 1 involves in vitro testing of its effectiveness, while Phase 2 is a clinical trial to assess safety, efficacy, and quality of life improvements for patients. The study aims to provide a scientifically backed solution for SCA management.
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