| CTRI Number |
CTRI/2022/02/040494 [Registered on: 22/02/2022] Trial Registered Prospectively |
| Last Modified On: |
14/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Evaluate The Safety and Efficacy of KSM-66 Ashwagandha®
capsule (300 mg) on Immune Function Enhancement and Quality of Life (QoL) in Healthy
Subjects |
|
Scientific Title of Study
|
A Prospective, Double Blind, Randomized, Parallel, Single-Center, Two-Arm, Placebo
Controlled Clinical Study to Assess the Efficacy and Safety of KSM-66 Ashwagandha®
capsule (300 mg) on Immune Function Enhancement and Quality of Life (QoL) in Healthy
Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suhas Kalashetti |
| Designation |
Principle Investigator |
| Affiliation |
Shree Samarth Hospital |
| Address |
Shree Samarth Hospital, 227, Omkar Appts, Karande Chowk, Rasta peth, Pune-411011, Maharashtra, India.
Pune
MAHARASHTRA
411011
India |
| Phone |
8805387387 |
| Fax |
|
| Email |
skalashetti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sornaraja Thasma |
| Designation |
Director Quality Assurance |
| Affiliation |
ProRelix Services LLP |
| Address |
ProRelix Services LLP
102 A/B, Park Plaza, Main Karve Nagar Chowk,
Karve Nagar, Pune, Maharashtra 411052
Pune, India
Pune
MAHARASHTRA
411052
India |
| Phone |
8124806366 |
| Fax |
|
| Email |
sthasma@prorelixresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sohal Pendse |
| Designation |
Director Business Operations |
| Affiliation |
ProRelix Services LLP |
| Address |
ProRelix Services LLP
102 A/B, Park Plaza, Main Karve Nagar Chowk,
Karve Nagar, Pune, Maharashtra 411052
Pune, India
Pune
MAHARASHTRA
411052
India |
| Phone |
9890096725 |
| Fax |
|
| Email |
s.pendse@prorelixresearch.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Ixoreal Biomed,Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana
500033 India |
|
Primary Sponsor
Modification(s)
|
| Name |
Ixoreal Biomed |
| Address |
Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana
500033 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Suhas Kalashetti |
Shree Samarth Hospital |
Clinical research department, Shree Samarth Hospital, 227, Omkar Appts, Karande Chowk, Rasta peth, Pune-411011, Maharashtra, India.
Pune
MAHARASHTRA |
8805387387
skalashetti@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immunity Boosting |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: KSM-66 Ashwagandha®, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo (Starch), Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult males and females between 18 to 60 years of age. (Apparently healthy, as determined by medical history, physical examination)
2. Subjects with Immune Status Questionnaire of less than 6
3. Participants who agree to take investigational product (i.e., Till day 56)
4. Literate subject willing to give signed informed consent.
5. Willing to comply with study protocol requirements.
|
|
| ExclusionCriteria |
| Details |
1. Participants who are not willing to take investigational product.
2. Any acute illness which may hamper the study participation as per PI discretion at the time of enrollment.
3. Individual participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements.
4. Patients with uncontrolled, unstable comorbidities.
5. Individuals with pre-existing respiratory conditions or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease.
6. History of allergic reactions or anaphylaxis to investigational product components.
7. Participants with a history of or those currently on immunosuppressants.
8. Pregnant and lactating females.
9. Any other condition which the principal investigator thinks may jeopardize the safety of subjects—patients with uncontrolled, unstable comorbidities.
10. Those with a history of clinically significant hypersensitivity reactions to immunomodulators. 11. Those with thyroid or pituitary disease
12. Those with immune system disease
13. Those with a history of systemic diseases such as multiple sclerosis, allergic skin disease and other autoimmune diseases
14. Those with a BMI of less than 18.5 kg/m2 at screening
15. Those who have received antipsychotic medication within 2 months before screening
16. Those with a alcoholism or history of substance abuse
17. Fertile women who do not accept the appropriate method of contraception (except for women who have undergone sterilization operation)
18. Participation in a clinical study during the preceding 90 days.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean levels of Serum Immune Biomarkers (NK Cell, CD4, CD8-T-Lymphocytes) |
Baseline and Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Change in mean levels of Serum Immune Biomarkers (IgA, IgG, IL-6, Interferon-Gamma, TNF-alpha levels) from baseline to end of study. (Time Frame: Baseline, Day 56)
•Number of Individuals displaying the improvement of Immune Health Status (questionnaire) between the groups. (Time Frame: Baseline, Day 56)
•Mean change in QoL status as determined by SF-12 (QoL) questionnaire from baseline to end of study. (Time Frame: Baseline, Day 56)
•Number of AEs between groups. (Time Frame: Baseline, Day 56)
• Perceived Stress Scale-10 (Time Frame: Baseline, Day 56)
•Patient’s Global Assessment of Tolerability to Therapy (PGATT)
|
Baseline and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2022 |
| Date of Study Completion (India) |
15/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sixty healthy male or female subjects of age 18-60 will be assigned in 1:1 ratio to treatment with the test product, KSM-6 Ashwagandha capsules or Placebo in this double-blind, randomized, placebo-controlled study. All 60 enrolled subjects will be instructed to take two capsules of either KSM-66 Ashwagandha or Placebo twice a day one capsule after breakfast and one capsule after dinner for 56 days daily. Subjects will be required to use diaries to document the date, time and dosage of study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with immune biomarkers in blood and secondarily with administration of immune health questionnaire, SF 12, PSS 10 and PGATT. |