| CTRI Number |
CTRI/2024/07/070723 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Process of Care Changes
Other (Specify) [Capsule] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the safety and efficacy of orally administered supplement SJ29 Capsule in sickle cell anemia patients |
|
Scientific Title of Study
|
A single-centered pilot scale study to evaluate the safety and efficacy of orally administered supplement SJ29 Capsule in sickle cell anemia patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Sunil Naik |
| Designation |
Assistant Professor of General Medicine |
| Affiliation |
Government Medical College and Govt General Hospital |
| Address |
Room no. 2, Government Medical College & Govt. General Hospital
2nd Floor, Beside FM Ward, Srikakulam-532001,
Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9440828299 |
| Fax |
|
| Email |
drsunilnaikggh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Hasan Ali Ahmed |
| Designation |
Director |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd |
| Address |
#252, 13th Cross, Wilson Garden, Bangalore-560027, KARNATAKA, India
Bangalore
KARNATAKA
560027
India |
| Phone |
9886012598 |
| Fax |
|
| Email |
hasan@xplorahealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Manik Chaudhuri |
| Designation |
Project Manager |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd. |
| Address |
#252, 13th Cross, Wilson Garden, Bangalore-560027, KARNATAKA, India
Bangalore
KARNATAKA
560027
India |
| Phone |
9738651205 |
| Fax |
|
| Email |
manik@xplorahealth.com |
|
|
Source of Monetary or Material Support
|
| Athulya Ayurvedic Medical Research Centre
Mundikkaltahzham, Medical College - Karanthur Road,
Kottamparamba P.O, Calicut-673008 Kerala, India |
|
|
Primary Sponsor
|
| Name |
Athulya Ayurvedic Medical Research Centre |
| Address |
Mundikkaltahzham, Medical College - Karanthur Road,
Kottamparamba P.O, Calicut-673008 Kerala, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dilip Kadam |
Care Multispeciality Hospital |
Kolte-Arcade, Pune-Nagar Road, Wagholi, Pune- 412207
Pune
MAHARASHTRA |
70661 15411
dr.dilipkadam12@gmail.com |
| Dr K Sunil Naik |
Government Medical College & Government General Hospital |
Room no.2, Clinical Research Dept.,
2nd Floor, Beside FM Ward, Srikakulam-532001,
Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH |
9440828299
drsunilnaikggh@gmail.com |
| Dr Abhijeeth Ganapule |
NICHE Hospital |
Plot No. 77,517A/1,E,Ward,Shivaji Park, Kolhapur-416001
Kolhapur
MAHARASHTRA |
9500817639
abhiganapule@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Care Multispeciality Hospital Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee GMC & GGH |
Approved |
| Mahalaxmi Health Care Pvt. Ltd |
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 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: SJ29 Capsule, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female over 18 to 30 years, both inclusive.
2. non smokers.
3. BMI greater than 18 kg/m2.
4. Patients diagnosed with sickle cell disease (documented by hemoglobin electrophoresis) and carrying SS or Sbeta0 version of the beta globin gene (documented by genotyping, known through medical history).
5. Hemoglobin levels between 5.5 and 10.5 g/dl during screening (for newly diagnosed or patients not on any treatment for SCD).
6. If the patient has been treated with an anti-sickling agent within three months with the intent to continue for the duration of the study.
7. Available to attend on an outpatient basis for visits provided for in the protocol and able to complete the data collection documents (compliance and quality of life scale)
8. Patient or the patients legally authorized representative has given written informed consent.
9. Able and willing to follow all study related instructions.
10. Must be willing to give written informed consent and comply with the study procedures. |
|
| ExclusionCriteria |
| Details |
1.Females who are pregnant or breastfeeding.
2.Patient has a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit.
3.Patient with diagnosed cancer in the past 2 years.
4.Patients participating simultaneously in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed.
5.Majors under legal protection or unable to express their consent.
6.People in an emergency situation unable to express their prior consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the efficacy of the intervention. (from day 1 to day 60) |
Day 1 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the safety of the intervention.
2. Reduction in pain and fatigue of the sickle cell anemia patients.
3. Number of days hospitalised due to acute SCD complications.
4. To improve the quality of life of patient. |
Day 1 and Day 60 |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| 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="0"
Months="7"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
A single-centered pilot scale study to evaluate the safety and efficacy of orally administered supplement SJ29 Capsule in sickle cell anemia patients.
Male or female patients with age over 18 to 30 years diagnosed with sickle cell anemia will be included. Total subject population is 10 subjects. Treatment period is from the day of screening i.e. day 1 to end of intervention of the supplement day 60. Study product is SJ29 Capsule, which subjects to receive daily oral dosing (3 capsules) of natural supplement from day 1 to day 60. Safety of the study intervention will evaluated by lab Investigations parameters: CBC with ESR, Reticulocyte count, LFT, LDH, C-Reactive Protein (CRP), Sickling test, Sr. creatinine, Urine analysis form mean change in these lab parameters from day 1 to end of study visit day 60. The efficacy of study intervention is evaluated by the McGill Pain Questionnaire (Pain tool). The benefit evaluation for this study is grounded in the potential positive impact of SJ29 capsule on sickle cell anemia. This supplement contains compounds that can help reduce the frequency and severity of painful episodes experienced by the patients suffering from sickle cell anemia, thus improving the overall quality of life for individuals. Supplement like this contain nutrients or bioactive compounds that support the function of red blood cells, potentially reducing the likelihood of sickle-shaped cells forming and causing blockages in blood vessels. This supplement is made of 100% herbal formula and helps to reduce the fatigue and pain. It also helps to regenerate healthy new RBC. The benefit evaluation is aligned with the broader goal of enhancing treatment options for sickle cell anemia and promoting overall health in affected individuals. The formulation of the capsule includes Boerhvia diffusa, Calotropis gigantea purified, Coscinium Fenestratum and Curcuma longa. SJ 29 capsule acts selectively to destroy diseased hemoglobin and blast cells. Overall, SJ29 improve the quality of life of patient.
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