| CTRI Number |
CTRI/2025/02/081387 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
HDCD-092330 tablet for uncomplicated cystitis |
|
Scientific Title of Study
|
A Prospective, Randomized, Double blind, Placebo Controlled, Two-arm, Comparative, Multicentric, Phase 2 Clinical Study to Evaluate the Efficacy & Safety of HDCD-092330 in Adults with Cystitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/050/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Somani |
| Designation |
Consultant Gyneacologist |
| Affiliation |
Altiuz Multispeciality Hospital and Research Centre |
| Address |
Altiuz Multispeciality Hospital and Research Centre
1st and 2nd floor Link house Opposite Icchapurti hanuman Mandir Malad Mumbai 400064
Mumbai
MAHARASHTRA
400064
India |
| Phone |
9987243896 |
| Fax |
|
| Email |
ankitas84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumawat |
| Designation |
Head Medical Services and Clinical Development |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room no 302 3rd floor Medical services and clinical development
department
Himalaya Wellness Company Makali Bangalore
KARNATAKA 562162
India
Bangalore Rural
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 Medical Services and Clinical Development (R and D) |
| Affiliation |
Himalaya Wellness Company |
| Address |
3rd floor Medical services and clinical development
department Himalaya Wellness Company Makali
Bangalore
KARNATAKA 562162
India
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
8067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company Makali Bengalore Karnataka 562162 |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company
Makali Bengaluru 562 162 India
|
| 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 Priyadarshini J |
Abhayahasta Multispeciality Hospital |
Abhayahasta Multispeciality Hospital
347/247 2nd Cross Kaggadasapura main road CV Raman Nagar Bangalore-560093
Bangalore
KARNATAKA |
9740067232
priyapaul1578@gmail.com |
| Dr Ankita Somani |
Altiuz Multispeciality Hospital and Research Centre |
Altiuz Multispeciality Hospital and Research Centre
1st and 2nd floor Link house Opposite Icchapurti hanuman Mandir Malad Mumbai 400064
Mumbai
MAHARASHTRA |
9987243896
ankitas84@gmail.com |
| Dr Shalini Maheshwari |
Gangasheel advanced Medical Research Institute |
Gangasheel Advanced Medical Research Institute
C-17 Deen Dayal Puram Rajendra Nagar Bareilly UP-243122
Bareilly
UTTAR PRADESH |
9837086762
drshalinimaheshwari@gmail.com |
| Dr Madhavender Jain |
Maharaj Agrasen Superspeciality Hospital |
Maharaj Agrasen Superspeciality Hospital
Sector 7 Central spine Vidyadhar Nagar Jaipur-302039
Jaipur
RAJASTHAN |
9413062961
madhavenderjain2@gmail.com |
| Dr Vinish Kumar Singh |
MV Hospital and Research Centre |
M.V. Hospital and Research Centre
314/30 Mirza Mandi Chowk
Lucknow Uttar Pradesh-226003
Lucknow
UTTAR PRADESH |
8073357800
mvhrclko@gmail.com |
| Dr Parth Dinehsbhai Patel |
Rhythm Hospital |
Rhythm Hospital,
D-201, SF, Fortune Atlantis, Kudasan, Gujarat-382421, India
Gandhinagar
GUJARAT |
8780089653
info@therhythmhospital.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee |
Approved |
| Institutional Ethics Committee Abhayahasta Hospital |
Approved |
| Institutional Ethics Committee for MV Hospital and Research Centre |
Approved |
| Institutional Ethics Committee Gangasheel Advanced Medical Research Institute |
Approved |
| Institutional Ethics Committee Maharaj Agrasen Superspeciality Hospital |
Approved |
| Rhythm Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N300||Acute cystitis, (2) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HDCD-092330 |
1 tablet twice daily orally after food for 28 days
(2 tablets twice daily to be titrated from Day14 to Day 28 in non-responders).
|
| Comparator Agent |
Placebo |
1 tablet twice daily orally after food for 28 days
(2 tablets twice daily to be titrated from Day14 to Day 28 in non-responders).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult female & male between18 to 60 years.
A.With at least two of the following mild to moderate signs or symptoms of Dysuria/Burning micturition, Increased Urinary frequency, Urinary urgency, Suprapubic pain
B. Along with Bacteriuria greater than 10,000 CFU/ml.
2. Male subjects with signs & symptoms of cystitis which do not require antibiotic therapy
3. Can signed informed consent and willing to participate and follow the study procedures
4. No concomitant participation in any other clinical trial since last 3 months
5. Women of child-bearing potential must agree to use adequate contraception during study period
|
|
| ExclusionCriteria |
| Details |
1. Subjects with clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, congenital, immunological or any other disorder as assessed by medical history
2. Subjects with signs or symptoms of fever greater than 102 degree fahrenheit, shaking chills, or other clinical manifestations suggestive of Complicated Cystitis as per Investigator discretion.
3. Subjects who are undergoing treatment with Antibiotics for the same or any other reason or within last 1 month.
4. Subjects taking dietary, herbal supplements or any other medication within last 10 days for the treatment of cystitis .
5. Subjects with history of neurogenic bladder, concomitant urogenital infection such as urethritis, vaginitis (for females), pyelonephritis, benign or malignant tumors or any other pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications
6. Male subjects with severe complicated cystitis secondary to prostatitis, epididymitis, benign prostatic hyperplasia, urolithiasis along with systemic symptoms requiring antibiotics, hospitalization or other surgical treatments for comorbidities.
7. Subjects diagnosed with renal insufficiency (renal failure, bilateral obstruction, or solitary kidney), Arterial aneurysm in vicinity of stones, Anatomical obstruction distal to stone, Kidney tumors, chronic kidney disease, sepsis, chronic infection or any other renal disease
8. Subjects with Uncontrolled Diabetes with HbA1c values greater than 9% in last 3 months.
9. Pregnant and lactating women.
10. Any other conditions physical, psychological, or social that can interfere with the subject’s compliance to the study in the opinion of the Investigator.
11. Subjects with known history of allergy to the study drug or any of its ingredients.
12. Known case of alcohol or any other substance abuse.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Improvement in microbiological response-Percentage of subjects with non-significant bacteriuria (less than103cfu/ml)
• Improvement in clinical response -Reduction in overall symptoms of cystitis
|
Visit 1: Screening (-10days to Day 0)
Visit 2: Baseline/ Day 1
Visit 3: Day 14 ± 3 days
Visit 4: Day 28 ± 3 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assess the adverse events observed or reported during the study period with ovrall compliance of the subject to the study intervention.
2.The evaluation of Quality of Life Quality using QOL scale
3. A proportion of subjects withdrawing from the study due to worsening of symptoms. |
Visit 1: Screening (-10days to Day 0)
Visit 2: Baseline/ Day 1
Visit 3: Day 14 ± 3 days
Visit 4: EOS/Day 28 ± 3 days
|
|
|
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)
|
20/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Participants will be examined for eligibility during the screening period after signing the informed consent form (within 10 days prior to Baseline). An adequate number of participants with cystitis/uncomplicated UTI will be screened to enroll 120 participants, to have at least 100 evaluable participants. Participants will be enrolled based on study eligibility criteria (inclusion and exclusion criteria). After signing the informed consent form, eligible participants will be randomized as per randomization, schedule either into active or in the placebo arm. All the participants will be given IP (active or placebo) on the same day. The date of first IP administration will be considered as Day1 and instructions about the dosage and timings will be given by Investigator as described in dosage & administration section. Non-responders or subjects not showing any improvement will be evaluated based on laboratory report and symptoms based on investigator’s discretion on visit 3 day 14 . Core Endpoints Improvement in microbiological response-Percentage of subjects with non-significant bacteriuria less than 10,000 cfu/ml Improvement in clinical response -Reduction in overall symptoms of cystitis by using Symptomatic Assessment There will be a total of 4 study visits for each participant. Visit 1: Screening (-10 days to Day 0) Visit 2: Baseline/ Day 1 Visit 3: Day 14 ± 3 days Visit 4: Day 28 ± 3 days/ EOS |