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CTRI Number  CTRI/2024/10/075982 [Registered on: 28/10/2024] Trial Registered Prospectively
Last Modified On: 18/04/2025
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 study the effects of PCA in participants. 
Scientific Title of Study   A Multicentre, Randomized, Double Blind, Parallel, Placebo Controlled Two Arm Study to Evaluate Safety and Efficacy of Orally Administered Protocatechuic Acid (PCA) capsule/ supplement. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PCAB-PCA-CT01-24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ganesh Avhad 
Designation  Principal investigator 
Affiliation  Lotus Holistic Healthcare & Aesthetic Clinic 
Address  5 brahma Chambers 2010 Sadashiv Peth Near Janata Bank Tilak Road, Pune Maharashtra

Pune
MAHARASHTRA
411030
India 
Phone  7378618618  
Fax    
Email  avhadganesh@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

Pune
MAHARASHTRA
411052
India 
Phone  8124806366  
Fax    
Email  s.thasma@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

Pune
MAHARASHTRA
411052
India 
Phone  9890096725  
Fax    
Email  s.pendse@prorelixresearch.com  
 
Source of Monetary or Material Support  
PCA Biosciences 6 Larkside Court, Henderson Nevada 89014 
 
Primary Sponsor  
Name  PCA Biosciences 
Address  6 Larkside Court,Henderson, Nevada 89014 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ganesh Avhad  Lotus Holistic Healthcare & Aesthetics Clinic  5 brahma Chambers 2010 Sadashiv Peth Near Janata Bank Tilak Road Pune 411030
Pune
MAHARASHTRA 		 7378618618

avhadganesh@yahoo.com 
Dr Vidyadhar Kumbhar  Sunad Ayurved   Shop no. 2,3,4, Jeevan Nagar, Dhoka colony, Opp. Dhoka Pratistan, Chinchwad, 411033
Pune
MAHARASHTRA 		 9960075536

dr.vidyadhar24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Independent Ethics committee Dhanashree Hospital Pune  Approved 
Independent Ethics committee Dhanashree Hospital Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male and female 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical PCA capsule  Placebo capsule, each capsule is of 500 mg. 4 capsules to be taken 2 hours before breakfast and dinner for 14 days. 
Intervention  PCA capsule  Test capsule, each capsule is of 500 mg. 4 capsules to be taken 2 hours before breakfast and dinner for 14 days. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects willing to provide a personally signed and dated informed consent prior to any study procedures; willing to comply with the study instructions and attend all scheduled study visits. 2. Males and females with age between 50 and 65 years, both inclusive. 3. Subjects willing to continue with their existing diet, exercise, and lifestyle habits throughout the study, without any change. 4. Subjects willing and able to comply with study procedures and duration. 5. Subjects willing to take the IP as per protocol defined dose and regime. 6. Non-menopausal & non-castrated women those are willing to use reliable methods of contraception to avoid pregnancy during the study. 
 
ExclusionCriteria 
Details  1. Subjects with allergy or sensitivity to any ingredient of Investigational product.
2. Participation in any clinical study within 30 days before
randomization.
3. Pregnant and lactating women.
4. Any kind of substance abuse, (alcohol, tobacco, or any other substance).
5. Subjects with uncontrolled metabolic diseases or chronic diseases at the discretion of the Investigator.
6. Subjects with unstable medical conditions as determined by the qualified Investigator.
7. Subjects with any planned surgery during the trial; history of any surgery past 3 months.
8. Current diagnosis of immune-compromised conditions like
HIV/AIDS, cancer.
9. History of blood/bleeding disorders; blood donation in the
previous 2 months.
10. Individuals who have had COVID-19 in the past three months.
11. Individuals with a history of major arthritis or joint problem.
12. Any other condition that in the qualified investigator’s opinion may have adversely affected the participant’s ability to complete the study or its measures or which may have posed a significant risk to the participant.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Monitoring and documentation of number and type of adverse events including changes in laboratory parameter (Complete blood count with differential, ESR, kidney function, liver function, lipid profile) from Baseline (Day 1) to the end (Day 14) of the study.
 		 Day 1, Day 14
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the efficacy of PCA capsules as compared to placebo based on personal health assessment test through SF 36 Survey, to evaluate the efficacy of PCA capsules as compared to placebo based on laboratory examinations (HbA1c, fasting blood glucose & post prandial Sugar, Hs CRP, IGF-1, IgA, IgG, CXCL9, GLP1 & Prothrombin time).  Day 1, Day 14 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   11/11/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

60 subjects will be screened (Considering 10% screen fail and 5% dropout to achieve 52 completed subjects for analysis). Eligible subjects of age 50- 65 will be assigned in 1:1 ratio to treatment with the test product, PCA Capsule or Placebo in this double- blind, randomized, placebo- controlled, parallel study. All enrolled subjects will be instructed to take 4 capsules of 500 mg (2000mg) of PCA and Placebo, 2 daily in the morning and 2 in evening, 2 hours before breakfast and dinner for 14 days. 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 HbA1c, fasting blood glucose & post prandial Sugar, Hs CRP, IGF-1, IgA, IgG, CXCL9, GLP1 & Prothrombin time. Primary objective is To determine safety and tolerability of PCA as compared to placebo in participants.

 
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