| CTRI Number |
CTRI/2022/02/040554 [Registered on: 23/02/2022] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate effect of KSM-66 Ashwagandha® Capsule (300 mg) in Management of Frailty in Older Adults |
|
Scientific Title of Study
|
A 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) in Management of Frailty in Older Adults |
| 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 |
Principal Investigator |
| Affiliation |
Govt. Medical College & Govt. General Hospital (Old RIMSGGH) |
| Address |
Govt. Medical College & Govt. General Hospital (Old RIMSGGH)
Srikakulam-532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9440828299 |
| Fax |
|
| Email |
rimsresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sornaraja Thasma |
| Designation |
Director Quality Assurance |
| Affiliation |
ProRelix Services LLP |
| Address |
102 A/B, 1st Floor, Park Plaza, near State Bank Colony, Karve Nagar, Pune, Maharashtra 411052
Pune
MAHARASHTRA
411052
India |
| Phone |
8124806366 |
| Fax |
|
| Email |
sthasma@prorelixresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sohal Pendse |
| Designation |
Director Operations |
| Affiliation |
ProRelix Services LLP |
| Address |
102 A/B, 1st Floor, Park Plaza, near State Bank Colony, Karve Nagar, Pune, Maharashtra 411052
Pune
MAHARASHTRA
411052
India |
| Phone |
9890096725 |
| Fax |
|
| Email |
s.pendse@prorelixresearch.com |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed, Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana 500033 India |
|
|
Primary Sponsor
|
| 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 K Sunil Naik |
Govt. Medical College & Govt. General Hospital (Old RIMSGGH) |
Department of clinical research, Research wing, Govt. Medical College & Govt. General Hospital (Old RIMSGGH)Srikakulam-532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH |
9440828299
rimsresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. Medical College & Govt. General Hospital (Old RIMSGGH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Frailty |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | 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: 1 capsule after breakfast and 1 capsule after dinner), Additional Information: - | | 2 | 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: 1 capsule after breakfast and 1 capsule after dinner), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Community-dwelling ≥60 years of age
2.Patient who can and willing to provide written Informed Consent
3.Patient with Frailty score of ≥7 based on FAST with normal cognition
4.Patient with at high risk for mobility disability/ functional limitations as assessed by the investigator
5.Patient able to independently ambulate
6.Patient who has received medical clearance from the investigator
7.Patient having capability of complete compliance and completion of follow-up
8.Patient who agree to take investigational product (IP) till Day 56
9.Patient/ patient’s legally acceptable representative understands and can comply with clinical trial protocol requirements
|
|
| ExclusionCriteria |
| Details |
1. Patient is currently under the inpatient-care of a geriatrician
2. Patient with significant cognitive impairment/Severe mental disorder determined by the investigator
3. Patient receiving palliative/end of life care/ life expectancy ≤6 months
4. Patients with MMSE score ≤ 20 points
5. Patient having a history or presence of clinically significant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease or malignant tumour.
6. Patients with history of alcoholism or substance abuse.
7. Patient who is not willing to take investigational product.
8.Patient who had recent hospitalization for major illness or elective surgery within 1-year of the start date of study.
9.Patient with any acute illness at the time of enrolment
10.Patient who has participated in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements, 1 month prior to this trial
11.Patient having an history of allergic reactions or anaphylaxis to investigational product components
12.Any other condition which the principal investigator thinks may jeopardize the safety of subjects—patients with uncontrolled, unstable comorbidities
13.Patients who had participated in other clinical trials during previous 3 months
|
|
|
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 |
| To evaluate the mean change of Frailty Score (FAST- Frailty Assessment and Screening Tool) between active and placebo groups |
Baseline and Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in 6-MIN walk test between baseline and Day 56
2.Assessment of PSQI (Pittsburgh Sleep Quality Index) between groups
3.change in (CRP, CORTISOL, CREATININE Kinase) levels between groups
4.Assessment of Memory and Cognition level using MMSE questionnaire
5.Assessment of SF 12 (QoL) between the groups.
|
Baseline and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/11/2022 |
|
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
|
The current
study was planned to evaluate the effectiveness
of KSM-66 Ashwagandha® capsule (300 mg) compared to
identical Placebo capsule in improving frailty of old adults.
Fifty older frail
patients aged will be included in this study. Patients will be enrolled into
the study based on Inclusion & Exclusion Criteria, patient history, and
safety measures. The duration of each patient’s participation in the study will
be of 56 days. There will be total 02 site visits and 01 telephonic interview
during the study.
On
screening/baseline visit, written informed consent will be obtained from
subjects for their participation in the study. Subject’s history will be
recorded and her physical examinations will be done. Subject will be recruited
in the study if he/she meets all the inclusion criteria. Subjects will undergo
general and systemic examinations. At baseline visit and end of treatment
visit, subjects will be provided with diary card to record daily symptoms. All
subjects will be advised to continue their routine diet and physical
activities.
Subjects will be called to the study centre on
Baseline & 56 the day from the baseline visit. On every physical visit,
subjects will undergo general and systemic examinations and assessment of
clinical symptoms will be done. There
will be a telephonic follow-up visit on Day 28 to check IP and Protocol
Compliance along with the AE detail collection.
Subjects
will be randomized to either one of the two treatment arms. Subjects will be instructed
to take the one capsule of study medication to which they are randomized, twice
a day after breakfast and dinner, with ambient temperature water for 56
consecutive days at home. All the patients will be closely monitored for any
Adverse Events starting from baseline visit till the end of the study visit.
After completion of 56 days of study treatment, all the subjects will be asked
to stop trial medication and take advice of investigator for further treatment. |