| CTRI Number |
CTRI/2023/04/051632 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of standardized Ashwagandha in healthy male volunteers |
|
Scientific Title of Study
|
A clinical study to evaluate safety of standardized Ashwagandha (Withania somnifera) extract capsules in healthy male volunteers |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/22-23/015 Version: 1.00 dated 16 Feb 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V G Vaidya |
| Designation |
Managing Trustee |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
4th-floor OPD 401 314 B Telco Road Chinchwad Pune
Pune
MAHARASHTRA
411039
India |
| Phone |
9822057766 |
| Fax |
- |
| Email |
vgvclinical@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth J Modi |
| Designation |
Junior Research Scientist |
| Affiliation |
Pharmanza Herbal Pvt. Ltd. |
| Address |
Plot 214, Borsad-Tarapur Road, Nr. Vadadla Patiya, At & PO:
Kaniya-388430, Ta: Petlad, Dist: Anand (Gujarat) India.
Anand
GUJARAT
388430
India |
| Phone |
8487941016 |
| Fax |
- |
| Email |
rdbiotech@pharmanza.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddharth J Modi |
| Designation |
Junior Research Scientist |
| Affiliation |
Pharmanza Herbal Pvt. Ltd. |
| Address |
Plot 214, Borsad-Tarapur Road, Nr. Vadadla Patiya, At & PO:
Kaniya-388430, Ta: Petlad, Dist: Anand (Gujarat) India.
GUJARAT
388430
India |
| Phone |
8487941016 |
| Fax |
- |
| Email |
rdbiotech@pharmanza.com |
|
|
Source of Monetary or Material Support
|
| Pharmanza Herbal Pvt. Ltd. Plot # 214, Borsad-Tarapur Road,Nr. Vadadla Patiya, At & PO:
KaniyaTa: Petlad, Dist: Anand (Gujarat) India -388430. |
|
|
Primary Sponsor
|
| Name |
Pharmanza Herbal Pvt. Ltd. |
| Address |
Plot # 214, Borsad-Tarapur Road,Nr. Vadadla Patiya, At & PO:KaniyaTa: Petlad, Dist: Anand (Gujarat) India -388430. |
| Type of Sponsor |
Other [Ayurvedic Industry] |
|
|
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 Amol Gothwad |
Lokmanya Medical Research Centre and Hospital |
4th-floor OPD 401-314
B Telco Road Chinchwad Pune
Pune
MAHARASHTRA |
9766400243
-
amol.gothwad87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Male Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Withania somnifera extract capsule |
500 mg capsule twice a day, after breakfast and after dinner
for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Male subjects having age between 18 to 60 years (both inclusive) 2. BMI between 18.5 and 24.9 kg/m2 (both inclusive) 3. Apparently mentally and physically healthy and biochemical parameters within normal reference ranges 4. Willingness to complete the study interventions and follow-up 5. Subjects with normal cardiovascular function with no evidence of acute ischemic heart disease in the electrocardiogram 6. The subject willing to provide consent and visit on follow up and abide protocol related requirements. |
|
| ExclusionCriteria |
| Details |
1. Being on a medically prescribed drug or supplements
2. Reported weight loss/gain >10% of body weight in the 6-month preceding pre-study examination
3. Using herbal supplements or dietary supplements meant for improving health and wellbeing
4. History of hypersensitivity to Ashwagandha
5. Undergoing medical treatment that may interfere with the study outcome
6. Consuming alcohol, smoking and/ or chewing tobacco during the past 6 months
7. Recreational drug use during the past 6 months
8. Subjects with diagnosis of an active disease and/or receiving pharmacological treatment prescribed for an active disease and who have evidence of an active disease at the time of the initial clinical examination at the discretion of the investigator
9. Any other major clinical disease or psychiatric disorder that, at the discretion of the investigator, precludes the administration or completion of the protocol treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Clinical laboratory examination of complete blood count (CBC), lipid profile, thyroid profile, liver function test (LFT), kidney function test (KFT), urine analysis, serum B12 levels, and CRP from screening to end of the study.
2. Observations in x-ray and ECG from screening to end of the study.
3. Vital signs from screening to end of the study. |
Screening visit, Baseline,
Visit 2(Day 15), Visit 3(Day 31) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Cardiorespiratory endurance by step test at screening and end of the study.
2. Body fat percentage and lean body weight by measuring skinfold thickness at four areas such as biceps, triceps, subscapular, and suprailiac with a Skin Fold Caliper in millimeters at screening and end of the study.
3. Adverse events profile from baseline to end of the study.
4. Tolerability of the investigational product from baseline to end of the study. |
Screening visit, Baseline,
Visit 2(Day 15), Visit 3(Day 31) |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/04/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Herbal nutraceuticals and functional foods have gained worldwide popularity since last decade due to increasing awareness about health among consumers. Withania somnifera (Ashwagandha), also known as “Indian Winter Cherry†is a valuable herb used as “Rasayana†to promote a youthful state for physical and mental health for over 3000 years. Roots of Withania somnifera have been used to prepare a tonic that enhances longevity, revitalizes the body, arrests the aging process and augment a defense against dreadful diseases, such as cancer, alzheimer’s and epilepsy. Withania species consist of chemical constituents from diverse chemical classes. Gaining knowledge and validating safety of active ingredients after oral administration is always of a great interest for food / nutritional products containing Withania somnifera.
The investigational product is formulated from the extract of Withania somnifera roots. The capsule containing single dose of 500 mg of standardized Withania somnifera root extract have been formulated for oral administration. The investigational product is Ayurvedic Proprietary Medicine and is considered and found to be safe to administer healthy human subjects. Considering the objective of interest as safety, the healthy human volunteers are proposed as study population for this study.
The present research is an attempt evaluate safety of Withania somnifera extract capsules in healthy male volunteers. |