| CTRI Number |
CTRI/2019/03/018204 [Registered on: 20/03/2019] Trial Registered Prospectively |
| Last Modified On: |
19/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to compare effect of draksha kalka with disodium hydrogen citrate ( syp Cital) in the symptomatic management of pittaj mutrakrucchra |
|
Scientific Title of Study
|
A randomized controĺled clinical trial of draksha kalka with disodium hydrogen citrate (syp.cital) in the management of pittaj mutrakrucchra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilesh Namdeo Muntode |
| Designation |
PG Second year |
| Affiliation |
college of ayurved and research centre |
| Address |
College of ayurved and research centre,sector 25, nigdi pradhikaran,Pune 411044.
Shalyatantra department,OPD No.123,Ayurved Rugnalay and sterling multispeciality hospital, sector 27 nigdi pradhikaran, Pune 411044.
Pune
MAHARASHTRA
411044
India |
| Phone |
9822101025 |
| Fax |
|
| Email |
nilmuntode@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Associate Professor, Shalyatantra department |
| Affiliation |
College of ayurved and research centre |
| Address |
College of ayurved and research centre,sector 25, Nigdi pradhikaran Pune 411044.
Shalyatantra department,OPD No.123.Ayurved Rugnalay and sterling multispeciality hospital, sector 27 nigdi pradhikaran, Pune 411044.
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Namdeo Muntode |
| Designation |
PG Second year |
| Affiliation |
college of ayurved and research centre,Nigdi |
| Address |
College of ayurved and research centre,sector 25, Nigdi pradhikaran,Pune 411044.
Shalyatantra department, OPD No.123. Ayurved Rugnalay and sterling multispeciality hospital, sector 27 Nigdi pradhikaran, Pune 411044.
Pune
MAHARASHTRA
411044
India |
| Phone |
9822101025 |
| Fax |
|
| Email |
nilmuntode@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of ayurved and research centre,sector 25, Nigdi. pradhikaran pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research centre |
| Address |
college of ayurved and research centre,sector 25, nigdi pradhikaran pune 411044 |
| 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 Nilesh Namdeo Muntode |
Ayurved Rugnalay and sterling multispeciality hospital |
Shalyatantra Department,OPD No.123. Sector 27, Nigdi pradhikaran, Pune 411044.
Pune
MAHARASHTRA |
9822101025
nilmuntode@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N309||Cystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Disodium hydrogen citrate |
Disodium hydrogen citrate (Syp.Cital) 15 ml with 50 ml of water for 7 days |
| Intervention |
Draksha Kalka |
Draksha kalka in 10-15 gm doses 12 hrly daily for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with cardinal symptoms of Pittaja mutrakruchhra mentioned
in Yogratnakar; chapter mutrakruchhrachikitsa
Patient having above 2 or more than complaints will be selected
ï€ Peetamutrata (Yellow dark colour )
ï€ Krichramutrata (Dysuria)
ï€ Sadahamutrata (Burning micturation)
ï€ Saraktamutrata (Hematuria)
ï€ Muhurmuhurmutrata.( Frequncy of urination) |
|
| ExclusionCriteria |
| Details |
Known case of:
1.Obstructive pathology like prostatic enlargement
2.Dibetes mellitus
3.Sexually transmitted diseases
4.Tuberculosis
5.Metabolic disorder
6.Renal failure.
7.Patient of chronic cystitis with bladder wall changes.
8.Benign or malignant tumors of bladder
9.Urethral Stricture
10.Any infective pathology |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Grading on the basis of Sadaha mutrapravruti, Sarakta mutrapravruti, Muhurmuhu mutrapravruti etc symptomatic relief |
observing symptomatic relief in 7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study adverse effects if any
2.To observe efficacy of Draksha kalka in the management of pittaj mutrakrucchra
3.To study effect of disodium hydrogen citrate (syp cital) in the management of pittaj mutrakrucchra |
Observation will be done before and after 7 days of treatment
|
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Mutrakruchchra is the disease of mutravahasrotas characterised by difficulty in micturition. The symptoms of different types of Mutrakrucchra particularly Pittaja Mutrakrucchra are similar to signs and symptoms of cystitis. Prodromal symptoms of Mutrakrucchra are sadahamutrapravrutti (burning micturition), muhurmuhurmutrapravrutti (increased frequency) and vedana in vankshana, medrabastipradesha (suprapubic and scrotal pain). Mutrakrucchra is one of the prime disease affecting mutravahasrotas (urinary system) involving the bastimarma (bladder). Vitiated tridosha due to different causes leads to obstruction (strotorodh) and inflammation (shobh) of the mutravaha strotas. Eight types of mutrakrucchra are describe in sushrut samhita by sushrutacharya.As Follows; 1.Vataj 2.Pittaj 3.Khaphaj 4.Sannipataj 5.Abhighataj 6.Purishaj 7.Ashmarij 8.Sharkara In Modern science, Syp Disodium hydrogen citrate is a drug of choice in the symptomatic treatment of cystitis. In my study I am going to study efficacy of Draksha Kalka in the management of Pittaj mutrakrucchra.
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