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CTRI Number  CTRI/2024/11/076572 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Test the Safety of HDCD-012435 in Healthy Volunteers. 
Scientific Title of Study   A Randomized Double-Blind Placebo Controlled Multiple Cohort Sequential Dose Escalation Phase 1 Clinical Study to evaluate the Safety and Tolerability of HDCD-012435 in Healthy Human Volunteers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HWC/MSCD/PP/015/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhu S N 
Designation  Principal Investigator 
Affiliation  TrialGuna Private Limited 
Address  #467, Room no 1, 2nd floor, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Not Applicable
Bangalore
KARNATAKA
560083
India 
Phone  9611484848  
Fax    
Email  madhusogala@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Kumawat 
Designation  Head Of Medical Services and Clinical Development 
Affiliation  Himalaya Wellness Company 
Address  Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore - 562162

Bangalore
KARNATAKA
562162
India 
Phone  8067549904  
Fax    
Email  rajesh.kumawat@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  Dr Soorya Narayan H 
Designation  Manager- Clinical Operations 
Affiliation  Himalaya Wellness Company 
Address  Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore 562162

Bangalore
KARNATAKA
562162
India 
Phone  08067549919  
Fax    
Email  dr.sooryanarayan.h@himalayawellness.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore - 562162 
 
Primary Sponsor  
Name  Himalaya Wellness Company 
Address  Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore - 562162 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhu S N   TrialGuna Private Limited  #467 Room no 1 2nd floor 1st Main Rd Royal Country 8th Phase Gottigere Bengaluru Karnataka
Bangalore
KARNATAKA 		 09611484848

madhusogala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult male or female subjects aged between 18- 45 years  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: HDCD-012435, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 800(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Cohort I- One tablet once daily. Cohort II- One tablet twice daily. Cohort III- Two tablets once daily. Cohort IV- Two tablets twice daily.
2Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 800(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Cohort I- One tablet once daily. Cohort II- One tablet twice daily. Cohort III- Two tablet once daily. Cohort IV- Two tablets twice daily.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Healthy adult male or female subjects aged between 18- 45 years.
2.Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests (as specified in Appendix1).
3.Subjects who refrain from taking any oral/ topical medication at least 15 days prior and during the study period. (SOS medications to be allowed during the study for any specific medical condition like paracetamol for
fever).
4.Subjects who have not participated in any other similar clinical study within the last 3 months of screening.
5.Women of child-bearing potential using reliable method of contraception within 2 months of screening and willing to adopt the reliable and validated contraceptive methods throughout the study period to avoid pregnancy.
6.Subjects willing to sign informed consent and follow the study procedure.
 
 
ExclusionCriteria 
Details  1.Subjects with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, congenital or any other systemic disorder that can interfere with the study conduct and outcome in the opinion of the Investigator. (Subject with any chronic medical condition under control to be also excluded).
2.Subjects with known history of GIT disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score (Appendix 2) more than 1 for any one of the 15 questions to be excluded).
3.Subjects with history of significant renal disease or urinary symptoms; past history of urinary stones, or history of any previous urogenital invasive procedures.
4.Subjects with known history or present condition of allergic response to the study product or any ingredients in the study product.
5.Pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications.
6.Pregnant and lactating women (as assessed by UPT & History of Amenorrhea).
7.Male subjects who is not willing to use adequate/ validated contraception and not willing to refrain from donating sperm from first admission to the study until 90 days after the follow-up visit
8.Known alcohol or any other substance abuse according to DSM-V criteria.
9. Any other reason (physical, psychological or social) that can interfere with
the subject’s compliance with the study in the opinion of the Investigator.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Assessment of safety of investigational product through general physical examination and laboratory investigations.
2.Incidence of adverse events during the study period.
 		 Day 1 & Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of Gastrointestinal tolerability through Gastrointestinal symptom rating scale.
2.Proportion of subjects withdrawing from trial because of adverse events. 		 Day 1 & Day 7 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   22/11/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This study is planned to be Randomized, Double Blind, Placebo Controlled, Multiple Cohort, Single and Multiple Dose, Sequential Dose Escalation Study. Subjects will be examined for eligibility during screening period after signing the informed consent form within 7 days prior to Baseline. Sufficient number of subjects will be screened for every cohort to enroll 10 subjects in each cohort total 4 cohorts, 40 subjects, to have at least 8 completed subjects in each cohort. Subjects will be enrolled based on study eligibility criteria inclusion and exclusion criteria sequentially. Subjects will be randomized either into active or in the placebo group in each cohort. All the subjects belonging to the same cohort will be given IP active or placebo on the same day. IP administration will start from Cohort 1 and the dosing schedule will be based on available safety & tolerability results of the preceding cohort as applicable. There will be a gap of a maximum of 7 days before administration to the next cohort. Same subject cannot participate in more than one cohort. To assess the safety and tolerability of HDCD-012435 in healthy volunteers. 
Study End points are Assessment of safety of Investigational Product through General Physical Examination & Laboratory Investigations. Incidence of adverse events during the study period. Proportion of subjects withdrawing from trial because of adverse events tolerability. Assessment of Gastrointestinal tolerability through Gastrointestinal Symptom Rating Scale.
 
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