| CTRI Number |
CTRI/2021/09/036297 [Registered on: 07/09/2021] Trial Registered Prospectively |
| Last Modified On: |
23/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Kutaja Beeja Churna and Ayurvedic Herbal Compound in the management of Urolithiasis |
|
Scientific Title of Study
|
Comparative study of efficacy of Kutaja Beeja Churna and Ayurvedic Herbal Compound in the management of Mutrashmari w.s.r. to Urolithiasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshay Kumar |
| Designation |
PG Scholar |
| Affiliation |
Mahatama Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 13 Department of Shalya Tantra Mahatama Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9899060658 |
| Fax |
|
| Email |
akshaykumarkaushik95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devyani Dasar |
| Designation |
HOD & Associate Professor |
| Affiliation |
Mahatama Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 13 Department of Shalya Tantra Mahatama Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503630392 |
| Fax |
|
| Email |
devyanidasar06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devyani Dasar |
| Designation |
HOD & Associate Professor |
| Affiliation |
Mahatama Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 13 Department of Shalya Tantra Mahatama Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503630392 |
| Fax |
|
| Email |
devyanidasar06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha Maharashtra 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical Sciences |
| Address |
Sawangi Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akshay Kumar |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room No 13 Department of Shalya Tantra Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) 442001
Wardha
MAHARASHTRA |
9899060658
akshaykumarkaushik95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N20-N23||Urolithiasis. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kutaja, Reference: Yogaratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Dadhi(Curd)), Additional Information: Kutuja Beeja Churna is to be used |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• Patients irrespective of occupation and economic status will be included
• Patient complaining of Nabhi basti sevni mehaneshu anaytam asmina mehati vedana (unilateral or bilateral pain in the renal angle, pain in lumbar region and radiating pain from loin to groin, pain in scrotum and inner aspect of thigh or pain in at least any one or more of above said sites).
• With or without dysuria. (mutra dhara sanga)
• With or without micro haematuria. (sarudhirmutrata)
• Patients with solitary or multiple urinary calculi present anywhere in urinary tract measuring between 5 to 9 mm size confirmed by USG abdomen and pelvis.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering with systemic disorders like HTN/ T2DM / HIV / Hepatitis etc.
2. Patients who are covid-19 positive.
3. Patients who were suffering with disorders like Renal Failure, Massive hydronephrosis, Tuberculosis, Cushings syndrome, Neoplasms, Polycystic Kidney, Urethral stricture, Meatal stenosis, Bladder neck contracture
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kutaja beeja churna will be useful for the management of Mutrashmari which will reduce pain, dysuria, hematuria and burning sensation and at the same time it will defragment the calculus and make it easier to pass through urinary tract. |
15th 30th 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| As Kutaja is easily available all over India hence this study will contribute to cost-effective, safe, readily available, simple preparation and a good remedy for managing Mutrashmari. |
60th 90th day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/09/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this Study Kutaja Beeja Churna and Ayurvedic Herbal Compound will be used for the management of Mutrashmari ( Urolithiasis ). Kutaja Beeja churna and Ayurvedic Herbal Compound will be taken by patients of trail and control group respectively twice a day for 45 days and assessment will be done on the basis of subjective and objective parameters to find out the medicine which is more effective in the management of Mutrashmari ( Urolithiasis ). |