| CTRI Number |
CTRI/2024/08/072615 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Mutrakricchahar Ghanvati in Mutrakrichha |
|
Scientific Title of Study
|
Prospective single arm open clinical trial to study the efficacy of Mutrakricchahar Ghanvati in mutrakrichha 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 Pradnya Govardhan Kashid |
| Designation |
PG Scholar |
| Affiliation |
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya , Satara |
| Address |
PG Department of Kayachikitsa
Dr M N Agashe Aryangla Hospital,Shukrawar Peth,Satara
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,ITI road,Gendamal,Satara 415002
Satara
MAHARASHTRA
415002
India |
| Phone |
9763295917 |
| Fax |
|
| Email |
pradnyakashid0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P D Londhe |
| Designation |
Professor and HOD of Kayachikitsa Department |
| Affiliation |
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya ,Satara |
| Address |
Cabin no 1 , PG department of Kayachikitsa , Dr M N Agashe Aryangla hospital, Shukrawar Peth,Satara
Seth chandanmal mutha aryangla vaidyak mahavidyalaya,ITI road, gendamal,satara
Satara
MAHARASHTRA
415002
India |
| Phone |
8830783292 |
| Fax |
|
| Email |
drpdlondhe4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradnya Govardhan Kashid |
| Designation |
PG Scholar |
| Affiliation |
Seth chandanmal mutha aryangla vaidyak mahavidyalaya, satara |
| Address |
PG Department of kayachikitsa Dr M N Agashe aryangla Hospital,Shukrawar Peth,Satara
Seth chandanmal mutha aryangla vaidyak mahavidyalaya,ITI road, gendamal, satara
Satara
MAHARASHTRA
415002
India |
| Phone |
9763295917 |
| Fax |
|
| Email |
pradnyakashid0@gmail.com |
|
|
Source of Monetary or Material Support
|
| sheth chandanmal mutha aryangla vaidyak mahavidyalaya satara maharashtra india 415002 |
|
|
Primary Sponsor
|
| Name |
Dr pradnya govardhan kashid |
| Address |
PG department of kayachikitsa , sheth chandanmal mutha aryangla vaidyak mahavidyalaya , gendamal , ITIroad , shahupuri, satara ,PIN 415002 |
| 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 pradnya govardhan kashid |
Seth chandanmal mutha aryangla vaidyak mahavidyalaya , satara |
room no 4, OPD block , department of kayachikitsa ,Dr m n agashe aryaangla hospital , satara, maharastra.
Satara
MAHARASHTRA |
9763295917
pradnyakashid0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SCM Aryangla vaidyak Mahavidyalaya satara |
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: MUTRASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: mutrakrichhahar ghanvati, Reference: sahastrayogam /, kashay prakaran ,page no 20 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -koshna jal ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient presenting with symptoms of Mutrakriccha with Urinary Tract Infection like Peeta Mutrata (Discolouration of urine), Bahurmutrata (Frequency of Urine), Sarakta Mutrata (Haematuria), Sadaha Mutrata (burning micturition), Saruja Mutrata (Painful Micturition), described in Ayurvedic classics
2 Without any bar of caste, sex, religion, occupation, socio-economic status.
3 Urine examination showing pus cells upto 30/hpf & RBC’s upto 15/hpf. |
|
| ExclusionCriteria |
| Details |
1 Pregnant and lactating mothers.
2 Patients with serious illness like HJV, malignancy, Severe Cardiac disease, Uncontrolled stage at HTN.
3 Pt having Auto Immune disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of mutrakricchar ghanvati in the managment of mutrakriccha |
7th day, 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the effect of Mutrakricchahar Ghanvati in Mutrakrichha
2 To Study the etiopathology of Mutrakrichha
3 To study the standardization of Mutrakricchahar Ghanvati.
4 To evaluate any adverse effect of Mutrakricchahar Ghanvati in Mutrakrichha if any. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/09/2024 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Article send to Ayurved Darpan Journal of Indian Medicine and Publication in progress |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pradnyakashid0@gmail.com].
- For how long will this data be available start date provided 07-09-2024 and end date provided 07-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
single arm open clinical trial this study is conducting for evaluate efficacy of mutrakricchahar ghanvati in the management of mutrakriccha with special referance to urinary tract infection after screening patients at OPD and IPD level 30 patients will be selected for trial, informed written consent will be taken in native langauge
Mutra refers to the urine and Krichrata refers to difficulty, hence disease Mutrakrichha include those forms of urinary disorders where Krichrata i.e. difficulty in the normal flow of urine is Dominant feature so all kinds of dysuria can be considered under this group. Urinary Tract Infection is one of the most common and potentially serious bacterial infection found Globally. It is common disorder accounting for 1-3% of consultations in general medical practice. According to Pub Med Central Article, Latest Prevalence rate of urinary tract infections are 10.1%. Where as, in Davidson’s principle and Practice for Medicine, it is about 37% .It is estimated that 40% women reported having UTI throughout their life. Typical features of UTI include frequency, urgency, dysuria, suprapubic pain during and after voiding, Urine appears cloudy, intense desire to pass more urine after micturition due to spasm of the inflammed bladder wall.
Null hypothesis- Mutrakricchahar Ghanvati 500mg orally two tablets twice a day for 14 days is not effective in Mutrakriccha with special reference to UTI.
Alternate hypothesis Mutrakricchahar Ghanvati 500mg orally two tablets twice a day for 14 days is effective in Mutrakriccha with special reference to UTI.
Drug – Mutrakricchahar Ghanvati â— Dose – 500 mg 2 tablets Twice a day â— Anupana – Koshna Jala â— Sevan Kala – Vyanodana (after food) â— Duration - 14 days â—Follow up - 7 th day , 14th day |