| CTRI Number |
CTRI/2020/06/026113 [Registered on: 24/06/2020] Trial Registered Prospectively |
| Last Modified On: |
19/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Kulatha Kwatha is effective in the management of Mootrashmari as compare to Syrup Ural.
|
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy of Kulatha Kwatha in the management of Mootrashmari. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhonappa Siddheshwar Bhanje |
| Designation |
MS Scholar ShalyaTantra |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research centre Pimpri Pune 411018 |
| Address |
ShalyaTantra OPD.No.03( Ground Floor),ShalyaTantra Department(3rd Floor)Dr.D.Y.Patil College of Ayurved and Research Centre,Pimpri,Pune 411018, Sant Tukaram Nagar,Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9730362092 |
| Fax |
|
| Email |
sarangbhanje@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeepkumar Jondhale |
| Designation |
HOD of ShalyaTanra Department |
| Affiliation |
Dr.D.Y.Patil College of Ayurved And Research centre Pimpri Pune. 411018 |
| Address |
ShalyaTantra OPD.NO.03(Ground floor),ShalyaTantra Department (3rd Floor),DR.D.Y.Patil college of Ayurved and research centre,pimpri,pune 411018.Sant Tukaram Nagar ,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7499597529 |
| Fax |
|
| Email |
pbjondhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhondappa Siddheshwar Bhanje |
| Designation |
Ms Scholar ShalyaTantra |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri ,Pune 411018 |
| Address |
ShalayTantra OPD.NO.03(Ground floor), ShalyaTantra Department (3rd Floor),DR.D.Y.Patil college of Ayurved and research centre pimpri pune 411018. Sant Tukaram nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9730362092 |
| Fax |
|
| Email |
sarangbhanje@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri, Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Dhondappa Siddheshwar Bhanje |
| Address |
Dr.D.Y.Patil College Of Ayurved And Research Centre Pimpri Pune 411018 |
| 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 Dhondappa Siddheshwar Bhanje |
Dr.D.Y.Patil College Of Ayurved and Research Centre , Pimpri Pune |
ShalyaTantra OPD.NO.03(Ground Floor) ShalyaTantra IPD (1st&2nd floor)DR.D.Y.Patil College Of Ayurved and Research Centre Pimpri Pune 411018 Maharashtra
Pune
MAHARASHTRA |
9730362092
sarangbhanje@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Recognition committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kulatha Kwatha. |
30 patient will be taken and treated with Kulatha Katha. Dose-40ml, Frequency-Twice a day(BID),Apan Kala(After Food) , Route- Orally, Duration-21 days.
|
| Comparator Agent |
Syrup Ural |
30 patients will take Support.Ural,Dose-10ml Syrup Ural, Frequency- Twice a day(BID), Route- Orally, Duration- for 21 days.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Size of calculus- A known diagnosed case having renal calculus up to 8mm.
Age group -18 to 60 years with irrespective of gender.
Patient of C/O-Udarshool (pain in abdomen), Sadah Mootra Pravrutti (Burning Micturition), Sarakta Mootra Pravrutti (hematuria) will be included.
Patients of either sex are taken irrespective of caste, religion and socio-economic status.
Though Patients having Mild to Moderate Hydronephrosis will be included in study ( i.e. Up to the Grade 3 of Hydronephrosis). |
|
| ExclusionCriteria |
| Details |
Age: below 18 and above 60 years.
Systemic diseases like malignancy, Kochs patients and medico-renal disease (M.R.D.) patient.
Renal failure, congenital disorder like ectopic kidney, horse shoe kidney, stricture at UV and PU junction, neoplasm.
Patients having severe Hydronephrosis/more than mild to moderate (i.e. Grade 4 of Hydronephrosis) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Kulatha Kwatha in Mootrashmari. |
30 patients will receive 40ml Kulatha Kwatha twice a day Apan Kala (After Food) for 21 days.Anupan Warm Water.
Follow up for 0 day, 7th day, 14, 21th day will be taken.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare effect of Kulatha Kwatha and Syrup Ural in Mootrashmari.
|
21days |
|
|
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 1 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study to give ayurvedic treatment. The suffuring from Mootrashmari. Which not only improve the condition but also protect from reccurance of the diseage along with this we can give safe, cheap and side effect free management in form of Kulatha Kwath. The trial will be condutect on 30 patient 40ml BID with Anupana Of Warm water and Another 30 patient’s give Syurp Ural 10ml BID. And conclusion will drawn from collected data. |