| CTRI Number |
CTRI/2019/03/017959 [Registered on: 07/03/2019] Trial Registered Prospectively |
| Last Modified On: |
09/04/2021 |
| 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 assess the effect of 100mg and 200mg Physta® (Eurycoma Longifolia) in aged male having low levels of sex hormone |
|
Scientific Title of Study
|
A double blind placebo controlled multicentric study to assess the effect of 100mg and 200mg Physta® on total testosterone, free testosterone level and quality of life in subjects having low testosterone level. |
| Trial Acronym |
SPOT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECPLCLN301018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pragya Pandey |
| Designation |
Principal Investigator |
| Affiliation |
Oriana Hospital, Varanasi, UP |
| Address |
Oriana Hospital B 27/35-9-A,
Ravindra Puri
Oriana Hospital B 27/35-9-A,
Ravindra Puri
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9696519115 |
| Fax |
|
| Email |
orianacrvns@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya Pandey |
| Designation |
Principal Investigator |
| Affiliation |
Oriana Hospital, Varanasi, UP |
| Address |
Oriana Hospital B 27/35-9-A, Ravindra Puri Oriana Hospital B 27/35-9-A, Ravindra Puri Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9696519115 |
| Fax |
|
| Email |
orianacrvns@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogendra Kumar Choudhary |
| Designation |
CEO |
| Affiliation |
Etica Clinpharm Pvt. Ltd. |
| Address |
CCRP-317, Ambuja City Centre, Vidhan Sabha Road, Mowa
Raipur
CHHATTISGARH
492001
India |
| Phone |
9039340075 |
| Fax |
|
| Email |
yogendrakumar.choudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| Biotropics Malaysia Berhad |
|
|
Primary Sponsor
|
| Name |
Biotropics Malaysia Berhad |
| Address |
Lot21,Jalan U1119, Section U1, Hicom-Glemarie Industrial Park, 40150 Shah Alam, Selangor, Malaysia |
| Type of Sponsor |
Other [Herbal & Nutraceutical Industry Global] |
|
|
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 Jitendra Anand |
Kanoria Hospital and Research Centre, |
Department of Clinical Research, Room no.1, Airport-Gandhinagar Highway,
Village Bhat
Gandhinagar
GUJARAT |
7923969274
jkanand09@gmail.com |
| Dr Govinda Narke |
Lokmanya Hospital |
Department of Community Medicine, Room no.1, Tilak road, Sector No. 24, Pradhikaran, Nigdi
Pune
MAHARASHTRA |
9011078989
narkegovinda@gmail.com |
| Dr Pragya Pandey |
Oriana Hospital |
Department of Gynecology, Room no.2, B 27/35-9-A, Ravindra Puri, Varanasi
Varanasi
UTTAR PRADESH |
9696519115
orianacrvns@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee, Kanoria Hospital and Research Centre |
Approved |
| Independent Research Ethics Committee, Pune (IRECP) |
Approved |
| ORIANA Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R888||Abnormal findings in other body fluids and substances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Physta |
Physta 100mg capsules (100 mg of standardized Eurycoma longifolia extract with 250 mg maltodextrin) and Physta 200mg capsules (200 mg of standardized Eurycoma longifolia extract with 150 mg maltodextrin). One Capsule once daily after breakfast for 90 days. |
| Comparator Agent |
Placebo |
280mg of maltodextrin. One Capsule once daily after breakfast for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1. Age 50-70 years, Male
2. BMI≥18 and ≤30.0 kg/m2
3. Testosterone levels <300 ng/dL
4. In a stable heterosexual relationship for at least 6 months
5. Volunteer must be able, willing and likely to fully comply with study procedures and restrictions.
6. Judged by the investigator to be in general good health on the basis of medical history.
7. Volunteer agree to not to take any other product which can boost testosterone during study period
8. Volunteer willing to sign the informed consent
|
|
| ExclusionCriteria |
| Details |
1. History of prostate cancer
2. Abnormal prostate exam (induration, asymmetry, or nodules)
3. Benign Prostate Hyperplasia symptoms
4. Penile anatomical abnormalities
5. Premature ejaculation
6. Cardiovascular disease
7. Resting hypotension (resting systolic blood pressure
<90mmHg)
8. Resting hypertension (resting systolic blood pressure
>170mmHg or diastolic pressure >110mmHg)
9. Primary hypoactive sexual desire
10. Volunteer taking any other investigation drug and currently being a part of any other clinical trial/research.
11. Any other underlying conditions which might affect serum testosterone levels (total and free).
12. Volunteers with known hypersensitivity to test drug or any of the excipients of this extract
13. Abnormal /Elevated kidney & liver function test
14. High alcohol intake (> 2standard drinks per day)
15. History of depression
16. Uncontrolled Diabetes
17. History of Seizures
18. Clinically significant chronic hematological disease
19. Significant active peptic ulceration
20. History of syncope within the last 6 months prior to entry to the study
21. History of malignancy within the past 5 years
22. Any congenital spinal cord deformities or traumatic spinal cord injuries
23. Any congenital or traumatic brain injuries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the serum total testosterone levels and free testosterone levels from baseline to the end of 90 days compared across two conditions (placebo and test product) |
At screening, day 14, day 30, day 60 and Day 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the BMI (Body Mass Index) from baseline to the end of 90 days compared across two conditions (placebo and test product) |
At screening or randomization, day 14, day 30, day 60 and Day 91 |
| Change in total score on the quality of life questionnaires including AMS (Aging Male Symptoms Score) and FSS (Fatigue Severity Scale) from baseline to the end of 90 days compared across two conditions (placebo and test product) |
At randomization, day 14, day 30, day 60 and Day 91 |
| Change in the levels of SHBG (Sex hormone binding globulin) and DHEA (Dehydroepiandrosterone) from baseline to the end of 90 days compared across two conditions (placebo and test product) |
At screening or randomization, day 14, day 30, day 60 and Day 91 |
| Change in the levels of HBA1C, IGF-1, Thyroxin Profile (T3, T4 & TSH), Free T3, Cortisol and muscle tone from baseline to the end of 90 days compared across two conditions (placebo and test product) |
At screening or randomization and Day 91 |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/03/2019 |
| Date of Study Completion (India) |
14/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a double
blind placebo controlled multicentric study to assess the effect of 100mg and
200mg Physta® on total testosterone, free testosterone level and quality of
life in subjects having low testosterone level. Physta®, is a patented
proprietary water-soluble standardized extract derived from Malaysian Eurycoma Longifolia roots. E. Longifolia is reported to have
aphrodisiac property, contributed by its testosterone enhancing effect. Instead
of containing testosterone itself, E.
longifolia works by promoting the production of testosterone naturally. E. Longifolia extract also possess
potent antimalarial activity, especially the activity against the
chloroquine-resistant Plasmodium falciparum. Moreover, E. Longifolia exerts proandrogenic effects that enhance the
testosterone level, as well as stimulate osteoblast proliferation and
osteoclast apoptosis. This will maintain bone remodeling activity and reduce
bone loss and thus possess osteoporosis preventive effect.
|