| CTRI Number |
CTRI/2024/04/065687 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To Investigate the Safety & Tolerability of HDCD-092330 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 & Tolerability of HDCD-092330 in Healthy Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/001/2024, Version 1.0, 1 Mar 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandrashekar S Ratkal |
| Designation |
Principal Investigator |
| Affiliation |
Clinic |
| Address |
467, 2nd floor, Room no 001, Department of clinical research, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
dr.csratkal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anindya Dasgupta |
| Designation |
Scientific Manager |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore – 562 162
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549920 |
| Fax |
|
| Email |
dr.anindya@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 – 562 162
Bangalore
KARNATAKA
562162
India |
| Phone |
8105466999 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company, Makali, Bengaluru – 562 162, India |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore – 562 162 |
| 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 Chandrashekar S Ratkal |
TrialGuna Private Limited |
467, 2nd floor, Room no 001, Department of clinical research, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
8867125414
dr.csratkal@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adults |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: HDCD-092330 (Cystone), Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 878(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 878(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
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. (Paracetamol to be allowed within 15 days prior to study, non-regular SOS medications to be allowed during the study)
4.Subjects who have not participated in any other similar clinical study within the last 3 months of screening.
5.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 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 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 drug or any ingredients in the investigational 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 refrain to use adequate contraception and not donate 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 to the study in the opinion of the Investigator.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety and efficacy
Assessment of GI (Gastrointestinal) tolerability through GSRS
(Gastrointestinal Symptom Rating Scale).
|
Day 1 & Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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/ Phase 2 |
|
Date of First Enrollment (India)
|
26/04/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Urolithiasis is formation of stones or calculi in the urinary tract that occurs when renal
stones exit the renal pelvis and move into the remainder of the urinary collecting system. These urinary stones may present with symptoms such as pain, nausea,
vomiting, hematuria, burning micturition and fever. The treatment of urolithiasis is based on parameters such as the size, number, and location. Studies seem to suggest that MET may increase the likelihood of stone passage in patients with distal
ureteral stones >5 mm and <10 mm in size. This is a Phase I safety study required to establish the safety of HDCD-092330 in healthy human volunteers. HDCD-092330 has been found to be safe in acute oral toxicity and repeat oral
dose toxicity studies in Wistar rats with a NOAEL at maximum feasible dose levels of 1000 mg/kg b.wt. As per the guidelines, healthy volunteers usually represent the ideal model for
conducting phase I clinical trials, in order to investigate drug response as well as to document safety
and tolerability without interference by concomitant pathological conditions. This study is designed to be randomized, placebo
controlled and double-blind study to establish unbiased safety and tolerability of HDCD-092330. In this study different set of healthy volunteers will be recruited in different cohorts
in sequential manner, to minimize the carry over effect of the preceding dosing regimen. |