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CTRI Number  CTRI/2023/03/050597 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 10/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial on Standardized Ashwagandha extract capsules. 
Scientific Title of Study   Pharmacokinetic study of Standardized Ashwagandha (Withania somnifera) extract capsules in Healthy Human Volunteers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/22-23/014 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  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ninad Naik  Lokmanya Medical Research Centre  4th-floor OPD 401-314 B Telco Road Chinchwad Pune Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9637785567
-
naikninaad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Medical Research Centre and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Standardized Ashwagandha (Withania somnifera) extract capsules   All subjects will receive single dose of 500 mg of Withania somnifera root extract capsule orally in sitting posture with 240 ± 2 mL of water at room temperature 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.Healthy male subject aged between 18 and 45 years (both inclusive).2.Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc. during the study and 07 days after completion of the study.3.Subjects with a BMI between 18.50-30.00 kg/m2 and body mass, not less than 50.00 kg.4.Subjects in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests).5.Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording.6.Subjects having a normal or clinically not significant chest X-Ray (P/A view).7.A negative alcohol breath test result.8.Subject able to communicate effectively and provide written informed consent.
9.Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee.10.Subjects that can provide adequate evidence of their identity.11.Availability of volunteers for the entire study duration.12.Ability to fast for at least 14.00 hours and consume standard meals. 
 
ExclusionCriteria 
Details  1.Known hypersensitivity to Ashwagandha (Withania somnifera) or related drugs or any component of this medication.2.Incapable of understanding the informed consent information.3.History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease or disorder.4.Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study.5.History or presence of alcoholism or drug abuse.6.History or presence of asthma, urticaria, or other allergic reactions.
7.History or presence of gastric and/or duodenal ulceration.8.History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion.9.History or presence of cancer.10.Difficulty with donating blood.11.Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week prior to study initiation and throughout the study.12.Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study.13.Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study.14.Subject consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study.15.Subject consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grapefruit juice and poppy-containing foods for at least 48.00 hours prior to initiation of the study and throughout the study.16.Major illness during the 90 days before screening.17.Participation in a drug research study within 90 days of screening.
18.Donation of blood within 90 days of screening.
19.Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL.20.History or presence of easy bruising or bleeding.21.Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study.22.Male volunteer unwilling to employ appropriate contraceptive measures to ensure that his partner will not get pregnant during the study till 07 days after the completion of the study.23.Male volunteers willing to donate sperm during the study till 07 days after the completion of the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Pharmacokinetics parameters like Cmax, Tmax, AUC0-t, AUC0-infinity, t1/2, Kel will be calculated from the concentration Vs. time data.  PK blood samples will be collected at pre-dose [within 45 min prior to IP administration] and post dose at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 9.00, 12.00, and 24.00 hrs. (Total 13 Time points). 
 
Secondary Outcome  
Outcome  TimePoints 
1.Safety assessments will include screening, pre-dose and post-dose vital signs, clinical examination, ECGs, clinical laboratory testing (hematology, blood chemistry, chest x-ray and urinalysis), and reporting of AEs and SAEs.
2.Monitoring and recording of adverse events, serious adverse events during the study period throughout the study. 		 From screening to end of the study 
 
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)   13/03/2023 
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 and a steady increase in life expectancy. 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. Due to the complexity in the characterization of chemical constituents of such medicinal plants, establishing pharmacokinetics and pharmacodynamics (PK-PD) relationships remained a challenge. However, knowledge of pharmacokinetics (PK) of active ingredients after oral administration is always of a great interest for food / nutritional products containing Withania somnifera. That is why the proposed study is planned to be conducted to study pharmacokinetics of active ingredients (Withanosides and Withanolides) of Withania somnifera root extract.

Subject’s disease condition, liver function, kidney function etc. greatly affect pharmacokinetics of any active ingredients; hence, healthy human subjects are always considered the best population to study pharmacokinetics of any active ingredients of such products. The investigational product Withania somnifera root extract is Ayurvedic Proprietary Medicine/nutraceutical product and hence is safe to administer healthy human subjects. Considering its safety, and considering the objective of interest as pharmacokinetics, the healthy human subjects are proposed as study population for this study.

The investigational product, capsule is formulated from the extract of Withania somnifera roots. The capsule containing single dose of 500 mg Standardized Withania somnifera root extract for oral administration, hence, the proposed route for this study is selected as oral administration. Single dose pharmacokinetics is sufficient at this stage of development; hence, the proposed study is planned as single dose pharmacokinetics study.

The present research is an attempt of exploration of pharmacokinetic profile along with the safety of the Standardized Ashwagandha (Withania somnifera) extract capsules in healthy human volunteers.

 
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