| CTRI Number |
CTRI/2025/01/079162 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Shatavaryadi kwath and Haritakyadi kwath for urinary tract infection. |
|
Scientific Title of Study
|
Comparative clinical study the efficacy of shatavaryadi kwath and haritakyadi kwath in the management of pittaj mutrakrucchhra with special reference to 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 Mohasin Hakim kankar |
| Designation |
PG scholar |
| Affiliation |
Shree Saptashrungi ayurved mahavidyalay and hospital Kamalnagar Hirawadi Panchavati Nashik |
| Address |
Kayachikitsa Department OPD no 2 ground floor Shree Saptashrungi ayurveda mahavidyalay and hospital Kamalnagar Hirawadi Panchavati District Nashik Maharashtra
Nashik
MAHARASHTRA
42003
India |
| Phone |
8459266634 |
| Fax |
|
| Email |
mohasinkankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somadatta Bhaskarrao Kulkarni |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Shree Saptashrungi ayurved mahavidyalaya and hospital Kamalnagar Hirawadi Panchavati Nashik |
| Address |
Kayachikitsa Department OPD no 2 ground floor Shree Saptashrungi ayurveda mahavidyalay and hospital Kamalnagar Hirawadi Panchavati District Nashik Maharashtra
Nashik
MAHARASHTRA
42003
India |
| Phone |
9860268117 |
| Fax |
|
| Email |
somdattak85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohasim Hakim Kankar |
| Designation |
PG scholar |
| Affiliation |
Shree Saptashrungi ayurved mahavidyalaya and hospital Kamalnagar Hirawadi Panchavati Nashik |
| Address |
Kayachikitsa Department OPD no 2 ground floor Shree Saptashrungi ayurveda mahavidyalay and hospital Kamalnagar Hirawadi Panchavati District Nashik Maharashtra
Nashik
MAHARASHTRA
42003
India |
| Phone |
8459266634 |
| Fax |
|
| Email |
mohasinkankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi ayurved mahavidyalay and hospital Kamalnagar Hirawadi Panchavati Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Dr Mohasim Hakim Kankar |
| Address |
Kayachikitsa OPD no 2 ground floor Shree Saptashrungi ayurveda mahavidyalay and hospital Kamalnagar Hirawadi Panchavati District Nashik |
| 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 |
| Dr Mohasim Hakim Kankar |
Shree Saptashrungi ayurved mahavidyalay and hospital Kamalnagar Hirawadi Panchavati Nashik |
Kayachikitsa OPD no 2 ground floor Shree Saptashrungi ayurveda mahavidyalay and hospital Kamalnagar Hirawadi Panchavati District Nashik
Nashik
MAHARASHTRA |
8459266634
mohasinkankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi ayurved mahavidyalaya and hospital Kamalnagar Hirawadi Panchavati Nashik |
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: Shatavaryadi kwath , Reference: Charak samhita Adhyay No 26/50, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu + Sharkara), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi kwath , Reference: Sharangdhar Samhita pratham khand 101, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having signs and symptoms of Pittaj Mutrakruchchra.
2 .The age group between 20 years to 60 years.
3.Patients irrespective of religion, sex and economical status.
4. Patients with uncomplicated urinary tract infection.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy & lactation
2.Prostate enlargement
3. Known case of Malignancy
4.Phimosis or paraphimosis
5. Known case of chronic kidney diseases, urinary calculus.
7. Traumatic causes
8. Known case of Uncontrolled diabetes
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the signs and symptoms of pittaj mutrakrucchhra |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of pittaj mutrakruchchra |
7 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/02/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
1. Primary Objective
To compare the efficacy of Shatavaryadi kwatha and Haritakyadi kwatha in Pittaj Mutrakrucchra with special reference to urinary tract infection
2 Secondary Objective
1. To study the disease Pittaj Mutrakrucchra in Detail According to Ayurved.
2. To Study urinary tract infection in Detail.
3. Study the efficacy of Shatavaryadi kwatha in Pittaj mutrakruchchra with special reference to UTI
4. Study the efficacy of Haritakyadi kwath in Pittaj Mutrakrucchra with special reference to urinary tract infection
Participant 70 Adults diagnosed with urinary tract infection meeting inclusion and exclusion criteria from OPD and IPD of department of Kayachikitsa of Shree Saptashrungi Medical College and Hospital Nashik
Interventions
35 patients Shatavaryadi kwath: Administered according to standardized protocol.
35 patients Haritakyadi Kwath: Administered according to standardized protocol.
Primary Outcome:
Reduce the signs and symptoms of pittaj mutrakrucchhra
Secondary Outcome:
No recurrency of pittaj mutrakrucchhra
Treatment Duration: 7 Days
Follow Up :0th, 7th days
Data Analysis: Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervension on the primary and secondary outcomes.
Ethical Considerations: The study will be conducted in accordance with ethical guidelines and with informed consent from participents.
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