| CTRI Number |
CTRI/2023/06/053893 [Registered on: 14/06/2023] Trial Registered Prospectively |
| Last Modified On: |
06/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Aamalaki kwath] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of efficacy of Aamalaki Kwath in treatment of Mutrakruchhra with special reference to cystitis |
|
Scientific Title of Study
|
Randomized open labelled controlled clinical study of efficacy of Aamalaki Kwath in treatment of Mutrakruchhra with special reference to cystitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujata Prataprao Chavhan |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved college and Hospital, Vazirabad, Nanded |
| Address |
Department of Shalyatantra Government Ayurved College Vazirabad Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9595079207 |
| Fax |
|
| Email |
sujatachavhan70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra H Amilkanthwar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved college and Hospital, Vazirabad, Nanded |
| Address |
Department of Shalyatantra Government Ayurved College Vazirabad Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9890569621 |
| Fax |
|
| Email |
drarajendrah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra H Amilkanthwar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved college and Hospital, Vazirabad, Nanded |
| Address |
Department of Shalyatantra Government Ayurved College Vazirabad Nanded
MAHARASHTRA
431601
India |
| Phone |
9890569621 |
| Fax |
|
| Email |
drarajendrah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College Vazirabad Nanded |
|
|
Primary Sponsor
|
| Name |
Dr. Sujata Prataprao Chavhan |
| Address |
Department of Shalyatantra Government Ayurved College Vazirabad Nanded |
| 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 Sujata Prataprao Chavhan |
Government Ayurved Hospital Nanded |
Department of Shalyatantra Hospital building OPD No.6 & 7 IPD ward No. 51 & 63
Nanded
MAHARASHTRA |
9595079207
sujatachavhan70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N30||Cystitis. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bruhat Dhatryadi Kwath, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Oral intake of Bruhat Dahtryadi kwath 40ml BID for 15 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aamalaki kwath, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Oral intake of Aamalaki kwath 40ml BID for 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient irrespective of gender,soscio- socio-economical status.
2. Age between 18-60 yrs.
3. Patient of Mutrakruchhra. |
|
| ExclusionCriteria |
| Details |
1. Patients having similar symptoms in the diseases other than cystitis such as severe renal function impairment, carcinoma within urinary tract, gross
hydronephrosis, pylonephrosis, severe obstruction uropathy, vesicle calculus.
2. Female patients of ANC, PNC, lactination and suffering from any acute
gynecological or obstetric disease.
3. Patient suffering from major illness like uncontrolled Hypertension, IHD, DM,
Asthma,T.B. etc.
4. Seriously ill patient of any disease.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased burning micturition |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Decreased burning micturition
2. Decreased haematuria
3. Decreased pain during/after micturition
4. Normal frequency of micturition |
30 days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/06/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is prospective, randomized, open labelled, controlled clinical study of use of Aamalaki kwath in treatment of Mutrakruchhra with special reference to cystitis. |