| CTRI Number |
CTRI/2024/10/075305 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Amalaki decoction with Haritakyadi decoction in the management of Urinary Tract Infection. |
|
Scientific Title of Study
|
Comparative clinical study of Amalaki Kwath with Haritakyadi Kwath in the management of Mutrakricchra. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Aishwarya Umesh Sonvalkar |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya Department of Kayachikitsa 1st
floor 583/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7972126792 |
| Fax |
|
| Email |
aishwaryasonvalkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhaychandra S Inamdar |
| Designation |
Associate Professor Kayachikitsa dept |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya Department of kayachikitsa 1st floor 583/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422003303 |
| Fax |
|
| Email |
drasinamdar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Aishwarya Umesh Sonvalkar |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya Department of Kayachikitsa 1st floor 583/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7972126792 |
| Fax |
|
| Email |
aishwaryasonvalkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramanath Charitable Ayurvedic Hospital 580/2 Rasta Peth Pune 411011 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Department OF Kayachikitsa 1st floor 583/2 Rasta Peth Pune 411011 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Aishwarya Umesh Sonvalkar |
Seth Tarachand Ramanath Ayurvedic Hospital Pune |
Tilak Ayurved Mahavidyalaya 1st floor kayachikitsa department rasta peth 583/2 pune
Pune
MAHARASHTRA |
7972126792
aishwaryasonvalkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe,TAMV Pune |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki Kwath, Reference: Bhaishajya Ratnawali 34/17, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Kwath, Reference: Bhaishajya Ratnawali 34/27, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Mutrakricchra,Diagnosed patients of Mutrakricchra according to classical signs and symptoms in ayurveda types of mutrakricchra included as vataj mutrakricchra and pittaj mutrakricchra. |
|
| ExclusionCriteria |
| Details |
1.Obstructive pathology like BPH.
2.Acute Urinary retention.
3.Paraphimosion.
4.Diabeties Mellitus
5.known cases of Sexually Transmitted Diseases (Gonorrhea,Syphilis,AIDS)
6.Tuberculosis,any Malignancy.
7.Traumatic injury to lower abdomen.
8.Renal calculi,Pregnancy.
9.High grade fever.
10.Types of Mutrakricchra like Ashmarijanya,Shukrajanya,Purishaj and shalyaj mutrakricchra.
11.urine pus cells more than 20/hpf |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Decrease in symptoms like
Burning Micturation,
pain.
2. Decrease in pus cell count |
7days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Decrease in symptoms like
Pain, burning sensation,
Urgency for Micturation.
2.Decrease in pus cell count & Epithilial cell count |
14 DAYS |
1.Decrease in symptoms like
Bastivedana,
Bastiguruta.
2.Decrease in pus cell count & Epithelial cell count |
21 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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
|
In this study Amalaki Kwath and Haritakyadi kwath will be given to the group A and B respectively. Efficacy will be assessed on the basis of Subjective and Objective criteria for statistical analysis.Gradations will be designed according to symptoms and each symptom wil be scored before and after treatment and every weekly follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis grading and scoring system .The signs and symptoms will be assessed by adopting the suitable scoring method . |