| CTRI Number |
CTRI/2023/03/051228 [Registered on: 31/03/2023] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to evaluate the efficacy of Ayurvedic drug in the treatment of renal stones |
|
Scientific Title of Study
|
A Randomized Controlled Clinical trial to Study the
Efficacy of Kadali Kwath in Comparison with Varunadi
Kwath in the Management of Mutrashmari |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAshok Devidas Pawar |
| Designation |
PhD Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822285836 |
| Fax |
|
| Email |
dr.ashok2575@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNandkishor Borse |
| Designation |
Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Dept Of Shalyatantra,Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411011
India |
| Phone |
9422032696 |
| Fax |
|
| Email |
drnvborse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAshok Devidas Pawar |
| Designation |
PhD Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Dept Of Shalyatantra,Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411011
India |
| Phone |
9422032696 |
| Fax |
|
| Email |
dr.ashok2575@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Tarachand hospital |
|
|
Primary Sponsor
|
| Name |
Ashok Devidas Pawar |
| Address |
Tilak Ayurved Mahavidyalaya Rasta Peth Pune 11 |
| 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 Ashok Devidas pawar |
Tarachand Hospital |
Shalyatantra OPD No-7
Rasta Peth Pune 11
Pune
MAHARASHTRA |
9822285836
dr.ashok2575@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Tilak Ayurved Mahavidyalaya Pune |
Approved |
| MESAM Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N202||Calculus of kidney with calculus of ureter. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: varunadi Kwath, Reference: Ayurved sar sangraha, Baidyanath ayurved bhavan, Reprint 2015, Kwath prakaran, page no 811., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Luke warm Water), Additional Information: varun has Properties of Ashmaribhedana(Stone expulsion) and Mutral(Diuretic) | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kadali(Banana), Reference: Shri Shaligram Vaishya,Brihat Nghantu Ratnakar volume-7-8th ,kadali Namani, Kadali sara guna and Kashtha kadali guna,Khemraj shrikrishnadas prakashan, Mumbai, 2002, page 419-424 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: Banana plant has medicinal properties, high potassium and sodium might be responsible for the diuretic effect. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having signs and symptoms of Mutrashmari.
2) Urolith of size up to 12 mm.
3) Genders : Both Males and females
4) Patients between age group 18 to 60 years
will be included.
5) Urolith seen in urinary tract as per USG.
|
|
| ExclusionCriteria |
| Details |
1) Seriously ill patients.
2) Obstructive uropathy leading to gross hydronephrosis, renal function impairment.
3) Pyonephrosis,
4) CA of urinary tract.
5) Gross hematuria.(Visible blood in the urine)
6) Having Urolith of size more than 12mm.
7) Pregnant and lactating women.
8) Patients with no symptoms of mutrashmari |
|
|
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 |
| To study the effect of Kadali Kwath in comparison with Varunadi Kwath in the management of Mutrashmari/ Urolithiasis |
Duration of treatment 30 days
Follow up on 15th and 30th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Kadali kwath in Mutrashmari( Renal and Ureteric stone) with expulsion of stone |
Duration of treatment 30 days
Follow up on 15th and 30 th days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
28/04/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE- A Randomized Controlled Clinical Trial To Study The Efficacy Of Kadali Kwath In Comparison With Varunadi Kwath In The Management Of Mutrashmari Null Hypothesis H0 – Kadali Kwath is as effective as Varunadi Kwath in the management of Mutrashmari Alternate Hypothesis H1- Kadali Kwath is more effective than Varunadi Kwath in the management of Mutrashmari Study design: Randomized controlled Clinical trial. Inclusion Criteria : 1) Patients having signs and symptoms of Mutrashmari. 2) Urolith of size up to 12 mm. 3) Genders : Both Males and females 4) Patients between age group 18 to 60 years will be included. 5) Urolith seen in urinary tract as per USG. Exclusion Criteria : 1) Seriously ill patients. 2) Obstructive uropathy leading to gross hydronephrosis, renal function impairment. 3) Pyonephrosis, 4) CA of urinary tract. 5) Gross hematuria.(Visible blood in the urine) 6) Having Urolith of size more than 12mm. 7) Pregnant and lactating women. 8) Patients with no symptoms of mutrashmari Sample Size -Total 70 (35 For each Group) Patients coming in IPD And OPD of Shalyatantra department of research institute hospital and working hospital, with complaint of mutrashmari. Simple Randomized Sampling. (Lottery Method). Group A – Kadali Kwath Group B – Varunadi Kwath Total duration of drug administration is 30 days. The mode of drug administration will be by oral route in the form of Liquid. Dietary support and oral hydrotherapy will be given in both groups. FOLLOW UP: Patient will be investigated on fifteenth & thirtieth day. Results-Result will be drawn on the basis of criteria of assessment and Statistical Analysis. |