| CTRI Number |
CTRI/2024/05/066786 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Study to Evaluate the Safety and Tolerability of in Healthy Human Volunteers for a period of 3 months for the safety endpoints.
|
|
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 HDLD-092320 in Healthy Human
Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/005/2024, Version 1.0, 26 Mar 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogananda Reddy R |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
467, 2nd floor, Room no 1, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
08867125414 |
| Fax |
|
| Email |
yogareddy77@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
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
Bangalore
KARNATAKA
562162
India |
| Phone |
08067549919 |
| 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 Yogananda Reddy R |
TrialGuna Private Limited |
467, 2nd floor, Room No 1, 1st Main Rd, Royal Country, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
08867125414
yogareddy77@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: HDLD-092320 (Liv 52), Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 650(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. Subjects with normal body mass index (BMI) 18.5-24.9 kg/m2
3. Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests.
4. 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).
5. Subjects who have not participated in any other similar clinical study within the last 3 months of screening.
6. 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.
7. Subjects willing to sign informed consent and follow the study procedure.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known clinically significant nervous, endocrinal, cerebrovascular, cardiovascular, respiratory, renal, genitourinary, 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 more than 1 for any one of the 15 questions to be excluded).
3. Subjects with known fatty liver disease grade 2 or more, history of chronic liver disease (like ALD/ NAFLD/MAFLD, chronic viral hepatitis like hepatitis B, C).
4. Subjects with known history of acute liver disease like acute hepatitis, within 6 months prior to the study.
5. Subjects with history of major surgery (like cholecystectomy) and major procedures like MRCP, ERCP.
6. Subjects with pre-existing systemic diseases (auto immune disorders, hormonal replacement etc.) necessitating long-term medications.
7. Subjects with any current infections (bacterial, fungal, viral) at the time of
screening as determined by the investigator.
8. Pregnant or lactating women (as assessed by UPT & history of amenorrhea).
9. 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.
10. Subjects who are not willing to refrain from alcohol or smoking from 48 hours prior and during the study.
11. Subjects with history of drug addiction or alcohol abuse within 5 years prior to the study
12. Subjects who undergo strenuous exercise within 7 days prior and during the study.
13. Any other reason (physical, psychological, or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator.
14. Subjects with known history or present condition of allergic response (like urticaria) to the study drug or any ingredients in the investigational product. |
|
|
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)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
11/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Liver is the second largest organ in human body, which has more than 5,000 separate bodily functions including coagulation, filtering toxins from the body, converting the food into nutrients, regulate hormone levels, fighting infections and illness, regeneration and repair, metabolism of cholesterol, glucose, iron and maintaining their levels and many other functions. Liver disease is the 11th leading cause of death and 15th leading cause of disability-adjusted life-years. The highest impact is on patients aged between 25 to 49 years. Herbal medicines have been widely utilized as effective remedies for the prevention and treatment of multiple health conditions for centuries by almost every known culture.: This Phase I study is designed to establish the safety of HDLD-092320 in healthy human volunteers. The design of this study is based on the principles of the USFDA, EMA & ABPI guidelines. |