| CTRI Number |
CTRI/2024/09/073602 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing 2 Ayurvedic medicines in Urinary Tract Infection |
|
Scientific Title of Study
|
A Comparative Clinical study to evaluate the effect of Gudaamalaki Kashayam and Atibala Kashayam in the management of Pittaja Mutrakricchram (Lower Urinary Tract Infection) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishali N |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet |
| Address |
Room no 17 , Dept of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7338879585 |
| Fax |
|
| Email |
vaishuvishali29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSuvendu Rout |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital , Nazarathpet, Chennai |
| Address |
Room no 17 , Dept of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444881980 |
| Fax |
|
| Email |
drsrout@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali N |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital , Nazarathpet, Chennai |
| Address |
Room no 17 , Dept of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7338879585 |
| Fax |
|
| Email |
vaishuvishali29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu, India 600123 |
|
|
Primary Sponsor
|
| Name |
DrVaishali N |
| Address |
Room no 17 , Dept of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu, India 600123 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVaishali N |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Room no 17 , Dept of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu, India 600123
Thiruvallur
TAMIL NADU |
7338879585
vaishuvishali29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital,Dept. of Ayurveda of SCSVMV, Nazarethpet, Chennai-600123 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: GUDAAMALAKI KASHAYAM , Reference: CHAKRADATTA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: ATIBALA KASHAYA, Reference: CHAKRADATTA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects having signs and symptoms of Pittaja Mutrakricchram either of the symptoms like
Daha, Ruja, Muhur-muhur Vega, Peeta or Rakta Varna Mootra
2.Urine pH of above 7.5.
3. H/O Recurrent urinary tract infection and uncomplicated urinary tract infection. |
|
| ExclusionCriteria |
| Details |
1.K/C/O Renal Calculi, Pyelonephritis, BPH, Urethral Stricture, Phimosis
2.K/C/O Diabetes.
3.Upper Urinary Tract Infection
4.Catheter-Associated Urinary Tract Infection
5.Spinal cord injuries, trauma to the urogenital tract
6.Pregnant and lactating mothers.
7.Patients below 18 years and above 70 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of UTI |
16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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="1"
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
|
UTI is defined as the presence and multiplication of bacteria in the urinary tract It is associated with a decrease in Quality of life and economical burden to the patients because of its heterogeneous nature with regard to its etiology, clinical manifestation and disease, which range from simple cystitis , urethritis till pyelonephritis, septic shock etc. Urinary tract infection may be of Uncomplicated UTI, Complicated UTI, Upper or Lower UTI. There are UPPER URINARY TRACT INFECTION [UUTI] involving kidney and LOWER URINARY TRACT INFECTION[LUTI] involving urethra, prostate, bladder Mostly 85% of UTI are caused by gram negative bacilli that are normal inhabitants of the intestinal tract. The enteric gram negative rods that have migrated to the urinary tract causes infections. UTIs are common in Pregnancy, Diabetes, Polycysticrenal disease, and in other Immune-compromised patients. |