| CTRI Number |
CTRI/2024/12/078750 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study on HDCD-092330 for the Treatment of Urinary Stones |
|
Scientific Title of Study
|
An Open label, Prospective, Randomized, Two-arm, Comparative, Multicentric, Phase 2 Clinical
Study to Evaluate the Efficacy and Safety of HDCD-092330 in Urinary Stones. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/049/2024 V1.0, Dated: 8 th Nov 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Javid Iqbal |
| Designation |
Consultant Urologist |
| Affiliation |
Alliance Hospital |
| Address |
room Number 5, Urology Department C-20/1-73, Ramakant Nagar
Pishch machan Varanasi
Varanasi
UTTAR PRADESH
221010
India |
| Phone |
9415359544 |
| Fax |
|
| Email |
drjaved_vns@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| 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
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
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
Bangalore
KARNATAKA
562162
India |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development(R&D), Makali Tumkur Road |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Javid Iqbal |
Alliance Hospital |
Room Number 5, Urology Department C-20/1-73, Ramakant Nagar, pishch machan Varanasi
Varanasi
UTTAR PRADESH |
7071724358
drjaved_vns@rediffmail.com |
| Dr Kanishk Dokania |
Charak Hospital & Research Center |
4rth floor, room number , urology department, Hardoi Raod, Dubagga, 226003
Lucknow
UTTAR PRADESH |
7704007112
rkslko.09@gmail.com |
| Dr Kiran Kumar M |
Excel Hospital |
1st Floor, Room Number-103, , Nephrology Department 1-5-56/29, old Alwal Near IG Statue Banda Basti, Alwal, Secunderabad.
Hyderabad
TELANGANA |
8788281252
Kirankumardr56@gmail.com |
| Dr Sanjay P Dhangar |
MAEERS VISHWARAJ HOSPITAL |
Urology department, Ground Floor, Room 10, GATE NO 499, Kadamvak vasti rajbaug pune Solapur, RD Loni Kalbhor pune Taluka haveli Pune 412201
Pune
MAHARASHTRA |
9326509990
drspdhangar@gmail.com |
| Dr Patil Amey Yashwanth |
Shree Siddhivinayaka Meternity & Nursing Home |
OPD Nno 5, 2nd Floor, shree Siddhivinayak hospital Unity Campus Opp, KTHM College, Gangapur Road 422002.
Nashik
MAHARASHTRA |
8956033598
ameyypatil@gmail.com |
| Dr T Senthilkumar |
SRM Medical College Hospital And Research Centre |
SRM MCH & RC Department of urology SRM IST, Room 4, 5th Floor Kattankulathur, Chengalpattu Tamil Nadu 603203
Chennai
TAMIL NADU |
9444226422
drsenku78@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Excel Hospital Institutional Ethics Committee |
Approved |
| IEC Charak Hospital and Research Centre |
Approved |
| IEC, Maeers Vishwaraj Hospital |
Approved |
| IEC- Namaste Integrated Services |
Approved |
| Shree Siddhivinayak Hospital Ethics Committee |
Approved |
| SRM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Cystone, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 530(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 42 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Supportive therapy | Supportive therapy will include Hydration & Rescue Medication (including analgesics, antispasmodics). Hydration: Subjects will be advised to drink more than 2 litres of water per day. For 42 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnosed with single or multiple urinary stones (kidney, bladder, or ureters) between 4mm and 7mm in size, as confirmed by USG KUB.
2.Subjects with or without symptoms related to urinary stones (e.g., flank or abdominal pain, possibly radiating to the groin or genitalia).
3.Subjects willing to avoid oral medication for stone-related disorders (except for analgesics and anti-spasmodics as needed).
4.Subjects who have not participated in any similar clinical study in the last 3 months.
5.Subjects willing to sign informed consent and adhere to the study procedures.
6.Women of childbearing potential and men with partners of childbearing potential must agree to use contraception (hormonal or barrier method) during the study and for 90 days afterward.
7.Male participants must refrain from sperm donation during the study and for 90 days following completion.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with severe symptomatic stones or stones more than 7mm or total burden more than 20mm.
2.Subjects with renal insufficiency, complicated UTI, kidney tumors, sepsis, or other renal diseases that may interfere with the study.
3.Subjects on medications (e.g., alpha blockers, corticosteroids, diuretics) within the past 15 days that may affect the study.
4.Subjects with significant chronic conditions (e.g., uncontrolled diabetes, hypertension) or any condition affecting study compliance.
5.Subjects allergic to the investigational product or its ingredients.
6.Pregnant or lactating women or those with a history of amenorrhea.
7.History of alcohol or substance abuse.
8.Any condition that may affect study participation in the investigator’s opinion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy:
Proportion of subjects with stone expulsion. (Stone Free Rate: SFR)
Time (mean days) to stone expulsion
Reduction in size of calculi/ total stone burden.
Use of Rescue medication (Analgesics, Anti-spasmodics)
Improvement in urinary symptoms
Pain Intensity Scale
Quality of life
|
Day 0, Day 1, Day 14, Day 28 & Day 42. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety:
Incidence of adverse events during the study period.
Proportion of subjects withdrawn from trial because of adverse events
(tolerability). |
Day 0, Day 1, Day 14, Day 28 & Day 42. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/01/2025 |
| 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 Yet Recruiting |
| 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
|
Trial
Title: An Open label, Prospective, Randomized, Two-arm, Comparative,
Multicentric, Phase 2 Clinical Study to Evaluate the Efficacy and Safety of
HDCD-092330 in Urinary Stones.
Protocol
Number: HWC/MSCD/PP/049/2024
Version
Number:1.0, Dated: 8 th Nov 2024
Objective:
To assess the effectiveness and safety of HDCD-092330 for treating urinary
stones.
Key
Details:
Study
Type: Interventional, open-label, randomized, two-arm, comparative.
Indication:
Urinary Stones (4mm to 7mm in size) and less 20mm stone burden.
Population:
Male and female subjects aged 18-55 with single/multiple urinary stones in the
kidney, bladder, or ureters.
Study
Arms:
Arm 1:
HDCD-092330 + supportive therapy (hydration, analgesics, anti-spasmodics).
Arm 2:
Supportive therapy only.
Duration
of Treatment: Up to 42 days per subject.
Number of
Subjects: At least 100 evaluable subjects.
Study
Visits:
Total 5
study visits for each subject:
Screening Visit: Subjects will be screened for
eligibility (within 7 days prior to Baseline).
Baseline
Visit/ Randomization (Day1): Baseline assessments will be conducted on eligible
subjects. Date of first IP administration shall be considered as Day1.
Day 14+3
days
Day 28+3
days
EOS Visit
(Day 42+3 days): All EOS assessments will be conducted on this visit.
Note: If
there is complete stone expulsion (confirmed by USG) on any of the follow up
visits or in between the scheduled visits, then EOS assessments shall be
conducted immediately. Participants shall continue in the study until a maximum
of Day 42+3 days Or until the stone expulsion date whichever is earliest
Study
Objectives:
Efficacy:
Proportion
of subjects with stone expulsion. (Stone Free Rate: SFR)
Time (mean
days) to stone expulsion
Reduction in size of calculi/ total stone
burden.
Use of
Rescue medication (Analgesics, Anti-spasmodics)
Improvement
in urinary symptoms
Pain
Intensity Scale
Quality of
life
Safety:
Incidence
of adverse events during the study period.
Proportion
of subjects withdrawn from trial because of adverse events (tolerability).
Dosage and
Administration:
HDCD-092330:
One tablet twice daily.
Study
Assessments:
Safety- General
physical examination, vital signs, and laboratory assessments.
Efficacy-
Ultrasound
(USG-KUB), pain intensity scale, and quality of life measures.
This study
will assess both the clinical efficacy of HDCD-092330 in managing urinary
stones and its safety profile through adverse event monitoring.
|