| CTRI Number |
CTRI/2024/04/066222 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to determine safety and efficacy of Sailin-HbS in Sickle cell disease patients |
|
Scientific Title of Study
|
Pathophysiological investigations of sickle cell disease and interventions to improve associated hemorheological abnormalities |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Suman Kundu |
| Designation |
Senior Professor |
| Affiliation |
Birla Institute of Technology and Science, Pilani K K Birla Goa Campus |
| Address |
Directors Office B-405
B Dome Building Department of Biological Sciences NH - 17B, Zuarinagar
Goa
South Goa
GOA
403726
India |
| Phone |
9834352929 |
| Fax |
|
| Email |
skundu@goa.bits-pilani.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Suman Kundu |
| Designation |
Senior Professor |
| Affiliation |
Birla Institute of Technology and Science, Pilani K K Birla Goa Campus |
| Address |
Directors office B-405,
B Dome Building
Department of Biological Sciences
NH - 17B, Zuarinagar
Goa
South Goa
GOA
403726
India |
| Phone |
9834352929 |
| Fax |
|
| Email |
skundu@goa.bits-pilani.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Rabindra Kumar Jena |
| Designation |
Professor and Head |
| Affiliation |
SCB Medical College and Hospital |
| Address |
Dept. of Clinical Haematology
Institute SCB Medical College and Hospital
Cuttack Odisha, India.
Cuttack
ORISSA
753007
India |
| Phone |
9437022343 |
| Fax |
|
| Email |
rkjena@msn.com |
|
|
Source of Monetary or Material Support
|
| BITS Pilani K K Birla Goa Campus
NH - 17B, Zuarinagar Goa, GOA 403726, India |
| Indian Council of Medical Research ,
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Sai Phytoceuticals Pvt Ltd
Address: S-553, Greater Kailash – II,
New Delhi – 110048, India |
|
|
Primary Sponsor
|
| Name |
Indian Council for Medical Research |
| Address |
V Ramalingaswami Bhawan, P I Box No 4911 Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BITS Pilani K K Birla Goa Campus |
NH 17B, Bypass, Road, Zuarinagar, Sancoale, Goa 403726 |
| Sai Phytoceutical P Ltd |
C-118 Industrial Area Mpavn Malanpur Distt Bhind Mandhya Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Rabindra Kumar Jena |
SCB Medical College and Hospital |
Office of the Professor & Head
Department of Clinical Haematology
1st Floor, Old Medicine Building
Cuttack 753007
Cuttack
ORISSA |
9437022343
rkjena@msn.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SCB Medical College and 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 | Other than Classical | | (1) Medicine Name: Sailin-Hbs, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 400(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard of Care | Tab Hydroxyurea
Duration: 12 months |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed cases of SCD with moderate to severe recurrent episodes who had experienced at-least 3 painful or vasoocclusive crises (VOC) in the previous year
2. Age between 5 to 45 years.
3. Homozygous sickle cell disease or Sbeta 0 thalassemia SS, SC, S beta thalassemia)as confirmed by CE electrophoresis (Gazelle Hb variant) and HPLC
4. Hemoglobin 5-10 gdL (both male and female)
5. Adults who are willing to use contraception during the course of treatment.
6. Willing to adhere to study procedures and to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Any acute sickle cell events that require hospitalization of patients within 1 month at enrollment.
2. Hemoglobin less than 5 gdL
3. Patients who received blood transfusion in last 3 months before enrollment.
4. Patients with clinical features of AIDS, Hepatitis or TB.
5. Patients with pregnancy or lactation
6. Patients with history of hypersensitivity reactions
7. Patients not willing or unable to follow instructions regarding treatment.
8. Patients with AST and/or ALT more than 3 times upper limit of normal or any sign of hepatic impairment or creatinine more than 2 times upper limit renal dysfunction
9. Patients with QTc interval of more than 470 msec at screening and patients with congenital long QT syndrome.
10. Chronic illness and pain disorders other than SCD such as leg ulcers, fever, fractures causing pain.
11. Is unstable or suffering from major psychiatric disorder such as schizophrenia or suicidal ideation
12. Refusal to provide access to relevant medical records or Consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Sailin-HbS by monitoring the following:
1) Reduction in the frequency of vaso-occlusive crises (VOC) by at least 33%.
2) Extension/prolongation of the interval between VOC occurrences by at least 33%. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in blood transfusion requirement by at least 33%. |
12 Months |
| To assess the effect of Sailin-HbS on the frequency of hospital admissions. |
12 Months |
| Assessment of safety and monitoring of adverse drug events. |
12 Months |
| To evaluate Sailin-HbS impact on markers of hemolysis, including lactate dehydrogenase (LDH) and liver function tests (LFT). |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
03/04/2025 |
| 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="3"
Months="0"
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
|
WHO recognized Sickle Cell Disease (SCD) as a global health pandemic, with approximately 2/3 of 300,000 children born with SCD annually in Africa and India, projected to climb to 400,000 by 2050. Current management and treatment options are inadequate and suboptimal. For such crisis, a new anti-sickling therapy is needed and previous attempts majorly focussed on synthetic molecules. Lack of systematic study and clinical trial with a cocktail of phytoconstituents based on traditional knowledge represents a major gap area. One such candidate formulation we developed, Sailin-HbS, demonstrated significant anti-sickling efficacy by impeding haemoglobin polymerization in-vitro as globin-oxygen affinity modifier and bears no toxicity in animal models. Preliminary clinical trial in African population was successful. Objectives: The study aims to evaluate clinical efficacy of Sailin-HbS as an anti-sickling formulation in Indian population. Additionally, metabolomics studies using liquid chromatography and inductively coupled plasma mass spectrometry will reveal disease pathophysiology. |