| CTRI Number |
CTRI/2021/11/038259 [Registered on: 25/11/2021] Trial Registered Prospectively |
| Last Modified On: |
24/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
study of Dhatryadi Kwatha and Shatavaryadi Kwatha in cystitis |
|
Scientific Title of Study
|
An open labelled, randomised, comparative clinical study to evaluate the efficacy of Dhatryadi Kwatha and Shatavaryadi Kwatha in Pittaj Mootrakrichchhra. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arjun Annasaheb Sable |
| Designation |
MD Scholar |
| Affiliation |
M A M Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD NO 2
Kayachikitsa dept
Ground floor
M A M Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
OPD NO 2
Kayachikitsa dept
Ground floor
M A M Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8482947594 |
| Fax |
|
| Email |
asable251194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachinkumar Patil |
| Designation |
MD Scholar |
| Affiliation |
M A M Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD NO 2
Kayachikitsa dept
Ground floor
M A M Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
OPD NO 2
Kayachikitsa dept
Ground floor
M A M Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822603608 |
| Fax |
|
| Email |
drsachinkumarpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Annasaheb Sable |
| Designation |
MD Scholar |
| Affiliation |
M A M Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD NO 2
Kayachikitsa dept
Ground floor
M A M Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
OPD NO 2
Kayachikitsa dept
Ground floor
M A M Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8482947594 |
| Fax |
|
| Email |
asable251194@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAM Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Arjun Sable |
| Address |
OPD NO 2
Kayachikitsa dept
Ground floor
M A M Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| 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 Arjun Annasaheb Sable |
Sane Guruji Aarogya Kendra |
OPD NO 2
Kayachikitsa dept
Ground floor
M A M Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8482947594
asable251194@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:N300||Acute cystitis. Ayurveda Condition: mootrakrichchhra, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dhatryadi Kwatha |
20 ml twice a day with anupan jala
route- per oral
duration- 5days |
| Comparator Agent |
Shatavaryadi Kwatha |
20 ml twice a day with anupan jala
route- per oral
duration- 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients will be selected from age group of 18 to 60 years irrespective of gender, religion, socio-economic status, marital status with informed written consent.
2.Patients presenting with cardinal symptoms of Pittaj Mootrakrichchhra mentioned in
Charak Samhita, Chikitsasthan 26 such as
1.Sapeeta mutrapravrutti
2.Sarakta mutrapravrutti
3.Muhurmuh umutrapravrutti
4.Sadaha Mutrapravrutti
5.Sashul Mutrapravrutti
Patient having above 2 or more complaints along with sadah mutrapravrutti.
|
|
| ExclusionCriteria |
| Details |
Diagnosed patient of
1.Uncontrolled Diabetes Mellitus and Known case of Diabetes Mellitus, Tuberculosis
2.Renal failure.
3.Patient of chronic cystitis with bladder wall change.
4.Benign or malignant tumors of bladder
5.Pregnant women.
Known case of Mutraghat, Ashmari (renal, vesicular calculus), Benign Prostate Hypertrophy, Urethral stricture, Phymosis, Tumours, Trauma to urogenital tract. Congenital causes and Obstructive pathology
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the efficacy of ‘Dhatryadi Kwatha’ in ‘Pittaj Mootrakrichchhra’ by clinical parameter.
Sapeeta mutrapravrutti,
Sarakta mutrapravrutti, Muhurmuhu mutrapravrutti, Sadaha Mutrapravritti,
Sashul Mutrapravritti
2.To assess the efficacy of ‘Dhatryadi Kwatha’ in ‘Pittaj Mootrakrichchhra’ by Routine examination of urine. |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To develop evidence based research for efficacy of ‘Dhatryadi kwatha’ in ‘Pittaj Mootrakrichchhra’.
2.To generate data of good standardized drug of herbal origin with good efficacy and less side effects. To study the changes in pH of urine with Dhatryadi kwatha
|
5 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/11/2021 |
| 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
|
Published in peer view journal after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
The Title of this Study is - An open
labelled, randomised, comparative
clinical study to evaluate the efficacy of Dhatryadi Kwatha and Shatavaryadi
Kwatha in Pittaj Mootrakrichchhra.
This study is planned to
assess the efficacy of Dhatryadi Kwatha on Pittaj Mootrakrichchhra and
to provide better option for its management. In developing country, disease
has more prevalence due to poor personal hygiene, mal nutrition, and
environmental condition. Pittaj Mootrakrichchhra is a disease
where Ayurveda offer a better hand than any other medical system.Scope of present work is
limited up to Pittaj Mootrakrichchhra only. Recurrence of
disease is very common. There are eight types of Mootrakrichchhra of
which Pittaj Mootrakrichchhra have symptoms like burning
micturation, frequent micturation. According to the symptoms of Urinary Tract
Infection (U.T.I.) and Pittaj Mootrakrichchhra, we can compare the
both in modern science. Hence, this
subject is considering for study, to assess the efficacy of Dhatryadi Kwatha
in Pittaj Mootrakruchchhra.In routine practice there are many
patients presenting with Mootrakrichchhra and hence to treat this many
trials have been done. Many Ayurvedic
preparation trials have been done for Pittaj Mootrakrichchhra Study.
For study Dhatri, Draksha, Vidarikand, Yashtimadhu, and Gokshur Yoga will
be used in the form of Kwatha for convenience and palatability. This
is an attempt to study the efficacy of
Dhatryadi Kwatha and Shatavaryadi Kwatha in Pittaj Mootrakrichchhra
in same dose, kala and duration. The contents of Dhatryadi
Kwatha i.e. Dhatri, Draksha, Vidarikand, Yashtimadhu,
and Gokshur are easily available and are cheap. Properties mentioned
in text are useful for Pittaj Mootrakrichchhra. This study will be
clinical evidence for Pittaj Mootrakrichchhra.In Ayurveda, Mootrakrichchhra
treatment has many formulations which are claimed to be effective in relieving
the symptoms, as Ayurvedic drugs taken in proper dosage &
continued treatment gives best result with minimal or no side effects.
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