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CTRI Number  CTRI/2022/04/041874 [Registered on: 13/04/2022] Trial Registered Prospectively
Last Modified On: 13/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Safety, Tolerability and Sensory evaluation of HTUL-031908 
Scientific Title of Study   An Open–Label Clinical study to evaluate the Safety, Tolerability and Sensory evaluation of HTUL-031908 in Healthy Adult Volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HWC/MSCD/PP/001/2022 Version: 1.0, Dated: 17 Jan 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR RAJENDRA NARAYAN SHARMA 
Designation  MBBS, MD 
Affiliation  TrialGuna Private Limited 
Address  TrialGuna Private Limited #467,1st Main, 4th Cross, Royal County Layout, JP Nagar 8th Phase, 2nd block, India

Bangalore
KARNATAKA
560083
India 
Phone  9740199006  
Fax    
Email  drrnsclinic@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swathi B 
Designation  Clinical Team Lead  
Affiliation  Himalaya Wellness Company 
Address  Clinical pharmacology, R and D, Makali, bengaluru Makali Bangalore Rural KARNATAKA
Makali
Bangalore Rural
KARNATAKA
562162
India 
Phone  8067547232  
Fax    
Email  dr.swathi.b@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  Dr Soorya Narayan H 
Designation  Manager Clinical Operations 
Affiliation  Himalaya Wellness Company 
Address  Clinical pharmacology, R and D, Makali, bengaluru Makali Bangalore Rural KARNATAKA
Makali
Bangalore Rural
KARNATAKA
562162
India 
Phone  8067549919  
Fax    
Email  dr.sooryanarayan.h@himalayawellness.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company 
 
Primary Sponsor  
Name  Himalaya Wellness Company  
Address  Tumkur road, Makali Bangalore India, Bangalore 562162  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 RAJENDRA NARAYAN SHARMA   TrialGuna Private Limited  #467,1st Main, 4th Cross, Royal County Layout, JP Nagar 8th Phase, 2nd block, India
Bangalore
KARNATAKA 		 9740199006

drrnsclinic@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adult Volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Turmeric latte, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 16(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Each subject must meet all the following criteria to be enrolled in this study:
1) Adult volunteers of either sex with good health.
2) Aged between ≥18 to ≤ 60 years.
3) Subjects willing to sign informed consent and follow the study procedure and instructions.
4) Has not participated in a similar investigation in the past four weeks.
5) Women in reproductive age group who will agree to follow an acceptable contraceptive method.
 
 
ExclusionCriteria 
Details  Subjects meeting any of the following criteria will be excluded from the study:
1) Subjects with clinically significant cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other systemic condition requiring therapeutic intervention.
2) A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the test products.
3) Pre-existing systemic disease necessitating long-term medications.
4) Genetic and endocrinal disorders.
5) Pregnant and lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To assess the safety of HTUL-031908 with number of adverse events observed or reported during the study period in healthy adult volunteers
2. To assess the tolerability and sensory evaluation of HTUL-031908 with total compliance to the study intervention
 		 •Visit 1 Screening/-1 week
•Visit 2 Day1/ screening
•Visit 3 Day 8/ End of study
 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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 1 
Date of First Enrollment (India)   15/04/2022 
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="0"
Days="7" 
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   This is an open label, clinical study to assess the safety, tolerability and sensory evaluation of test product an herbal formulation (HTUL-031908) in total 12 healthy adult volunteers for a period of 7 days. 

All subjects will be evaluated for the tolerability of the intervention at the end of Day 8 as compared to the baseline. All the subjects will be instructed regarding the study procedure and the follow up visits and information regarding the contact person during emergency. All the subjects will be explained regarding the investigations and the sensory evaluation that will be carried out during the study period [Screening and Day 8 (End of the study visit)]. Subjective, objective and sensory parameters will be considered for evaluation to assess the safety, tolerability and sensory evaluation of the test product (HTUL-031908). Assessment will be done at Day 3 and Day 8 (End of study) as compared to the baseline. Study related data from each subject will be collected and recorded in the Case Report Form and will be considered for statistical evaluation. Safety assessment was done by assessing any adverse events reporting done by both the subject and the investigator in the CRFs.


These assessments thus helped to evaluated the safety, tolerability and sensory consequences on the participants before and after the study thus evaluating the safety tolerability and sensory effects of the test product. 
 
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