| CTRI Number |
CTRI/2023/06/053490 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Extend Comparative Study Of Swetaparpati And Gokshurpunarnavadi Yoga In The Treatment Of The Renal Stone. |
|
Scientific Title of Study
|
An Extended Comparative Clinical Study Of Sweta Parpati And Gokshurpunarnavadi Yoga (Anubhut) In The Management Of Renal Stone (Vrikkashamari) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipaben Govindbhai Kanani |
| Designation |
PG Scholar |
| Affiliation |
Government Akhandanad Ayurved College Ahmedabad |
| Address |
Opd No.24,Shalya Tantra Department, Goverment Akhandanand Ayurveda College,Bhadra,Ahmedabad.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9687353123 |
| Fax |
|
| Email |
knanidipa17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVipulkumar V Sangani |
| Designation |
Lecturer |
| Affiliation |
Government Akhandanad Ayurved College Ahmedabad |
| Address |
Opd No.24,Shalya Tantra Department, Goverment Akhandanand Ayurveda College,Bhadra,Ahmedabad.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9998960732 |
| Fax |
|
| Email |
drvipulvsangani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVipulkumar V Sangani |
| Designation |
Lecturer |
| Affiliation |
Government Akhandanad Ayurved College Ahmedabad |
| Address |
Opd No.24,Shalya Tantra Department, Goverment Akhandanand Ayurveda College,Bhadra,Ahmedabad.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9998960732 |
| Fax |
|
| Email |
drvipulvsangani@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AKHANDANAND AYURVED COLLEGE AND HOSPITAL,BHADRA AHMEDABAD,GUJARAT,INDIA.380001 |
|
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Primary Sponsor
|
| Name |
GOVERNMENT AKHANDANAD AYURVED COLLEGE |
| Address |
OPD NO.24 SHALYATANTRA DEPARTMENT ,GOVERNMENT AKHANDANAD AYURVEDA COLLEGE AND HOSPITAL,BHADRA,AHMEDABAD. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dipa Kanani |
Government Akhandanand Ayurveda Hospital |
OPD NO.24 SHALYATANTRA DEPARTMENT ,GOVERNMENT AKHANDANAD AYURVEDA COLLEGE AND HOSPITAL,BHADRA,AHMEDABAD.
Ahmadabad
GUJARAT |
9687353123
knanidipa17@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: ASMARI, (2) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: ASMARI, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sweta parpati, Reference: siddha yoga sangrah, Route: Oral, Dosage Form: Parpati, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -coconut water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Gokshurpunarnavadi Yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -plain soda), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age Group Between 18 to 60 Years.
2.Patients Presented with classical symptoms of RENAL STONE.(Flank pain,Nausea,Vomiting,Sweating,Haematuria)
3.Patients having Calculus size upto 10mm.
4.After Surgery (One Side Nephrectomy) Patient having one kidney. |
|
| ExclusionCriteria |
| Details |
1.Patients below 18years and above 60years to be excluded from the study.
2.Patients having calculus size more than 10mm.
3.Uncontrolled Diabetes (HbA1c>6.5) and Hypertension(more than 150/90mmhg).
4.Patients With Obstructive Pathogenesis like BPH,Urethrel Stricture etc.
5.Patients associated with Complications like Pyonephrosis,Gross Hydronephrosis,Gross Hydroureter,CRF.
6.Known Cases of Malignancy.
7.Severe Systemic diasease like TB,HIV ETC. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1)Assess Reduce Stone Size
2)Assess Relief in Symptomps |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess Improve Of Quality Of Life |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2023 |
| Date of Study Completion (India) |
16/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
An extended comparative clinical study of sweta
parpati and gokshurapunarnavadi yoga (anubhut) in the management of renal stone
(vrikkashmari)
Introduction
Ashmari comprises of two words, I.e.Ashma means a stone and Ari means Enemy. Ashmari is a disease in which there is
formation of stone , resulting into severe pain as given by enemy. As per
Shusruta samhita Ashmari is included in Ashtomahagada (Eight dreadful disease)
due to It’s notorious nature and reluctant to cure.
In western medical science,the best possible
treatment for urinary calculus are use of certain medicine including various
diuretic as well as surgical intervention which in Closed and Open
surgery,PCNL,ESWL,URS etc. However all this method have high chances of
recurrence due to its peculiar tendency and it is also an expensive affair,even
after surgery patients have to take medicine to check it is further recurrence.
Therefore it is necessary to find out an economical, effective, easily
available and acceptable medicine to treat RENAL STONE.
Hence in this present clinical study, Sweta parpati
& Gokshurapunarnavadi yoga are selected for the management of Vrikkashamri.
Research question
Whether Gokshurapunarnavadi yoga (anubhuta) is more
effective than Sweta parpati (s.y.s) in the management of RENAL STONE or not
?
Hypothesis
Null Hypothesis (H0): There is no difference in the
effect of Swetaparpati and Gokshurapunarnavadi yoga in the management of RENAL
STONE.
Alternative Hypothesis (H1): Sweta parparti is more
effective than Gokshurpunarnavadi yoga in the management of RENAL STONE.
Alternative Hypothesis (H2): Gokshurpunarnavadi
yoga is more effective than Sweta parpati in the management of RENAL
STONE.
Aim
To compare the clinical effect of Sweta parpati and
Gokshurapunarnavadi yoga in the management of RENAL STONE.
Objectives
1.To evaluate the clinical efficacy of Sweta
parpati and Gokshurapunarnavadi yoga in the management of RENAL STONE.
2.To understand the pathophysiology of RENAL
STONE from Ayurvedic as well as modern point of Views.
Drug review
Group A (Control group):- Swetaparpati (s.y.s) with
coconut water (Acidic) for 30 days
No. Of patient:20
Route:Orally
Dose:1gm
Time(After
meal):Twice a day
Duration:30 days
Group
B (Trial group) :-Gokshurapunarnavadi churna (Anubhutyoga) with soda water for
30 days
No. Of patient:20
Route:Orally
Dose:3gm
Time(After
meal):Twice a day
Duration:30 days
Diagnostic criteria
- Subjective criteria:
- Flank pain
- Nausea
- Vomiting
- Sweating
2.Objective criteria
- Rakta mootrata
- Size of calculus by USG
- Number of calculus by USG
Follow up:
After completion of treatment for 1 month,all
the patients to be instructed to visit for regular Follow up at seven days
interval for the period of 1 month.
PATHYA-APATHYA:
Written Pathya-Apathya chart will be
provided to patients as per classical texts.
Benifits:
Project will help us to solve research
question.Whether Gokshurpunarnavadi yoga is more effective than Sweatparpati in
the management of Renal stone or not. Collected information from this project
will be kept confidential, all outcomes will be noted in tabular form and
appropriate statistical tests will be applied.
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