| CTRI Number |
CTRI/2024/06/069545 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| 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
|
Ayurvedic treatment in renal calculi |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of arka paneeya kshara and apamarga paneeya kshara in the management of mutrashmari (Urolithiasis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavankumar D S |
| Designation |
Postgraduate resident |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Room no 4 Department of shalya tantra Dr N A Magadum Ayurvedic Medical Hospital, Ankali Tq- Chikodi Dist- Belagavi
Belgaum
KARNATAKA
591213
India |
| Phone |
9481217373 |
| Fax |
|
| Email |
pavankumards885@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Duradundi Gudasi |
| Designation |
Professor and HOD department of Shalyatantra |
| Affiliation |
Dr N A Magadum Ayurvedic MEdical College, Hospital and Research Centre |
| Address |
Dr N A Magadum Ayurvedic Medical College, Hospital and Research Centre, Ankali Tq- Chikodi Dist- Belagavi
Belgaum
KARNATAKA
591213
India |
| Phone |
9743192805 |
| Fax |
|
| Email |
duradundi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Duradundi Gudasi |
| Designation |
Professor and HOD department of shalyatantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Room No4,department of shalya tantra Dr N A Magdum Ayurvedic medical colllege Ankali Tq- Chikodi Dist- Belagavi
Belgaum
KARNATAKA
591213
India |
| Phone |
9743192805 |
| Fax |
|
| Email |
duradundi85@Gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical College, Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Pavankumar D S |
| Address |
Dr N A Magadum Ayurvedic Medical college, hospital and research centre, Ankali 591213
Tq-chikodi Dist- Belagavi, Karnataka, India |
| 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 Pavankumar D S |
Dr N A Magadum Ayurvedic Medical college hospital and Research centre |
Room No4, Department of shalya tantra ,Ankali Tq- Chikodi Dist- Belagavi
Belgaum
KARNATAKA |
9481217373
pavankumards885@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. N A Magadum Ayurvedic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N22||Calculus of urinary tract in diseases classified elsewhere. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arka paneeya Kshara , Reference: Sushruta samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Sukoshna jala ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Apamarga paneeya kshara , Reference: Sushruta samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Sukoshna jala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with clinical features of urolithiasis like pain abdomen, burning micturation, maematuria, size of calculi less than 10mm, number of calculi less than or equal to 4 |
|
| ExclusionCriteria |
| Details |
contraindication of paneeya kshara, patient suffering from moderate to severe hydronephrosis, staghorn calculus, impacted calculi, stone which is present on lower pole of kidney, pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| presence of calculi |
before treatment and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduce in the sumptoms and size of calculi |
before treatment and 28th 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pavankumards885@gmail.com].
- For how long will this data be available start date provided 30-06-2024 and end date provided 30-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The present study Titled " A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARKA PANEEYA KSHARA AND APAMARGA PANEEYA KSHARA IN THE MANAGEMENT OF MUTRASHMARI (UROLITHIASIS)" will be conducted on 60 subjects with 30 in each group with mentioned objective and subjective parameters. One group will be treated with Arka paneeya kshara and another group with Apamarga paneeya kshara orally with sukoshna jala. assesment of patient will be done before the treatment and after treatment (28th day). |