| CTRI Number |
CTRI/2025/04/085995 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| 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
|
Management of Renal calculi with Shankhdrav. |
|
Scientific Title of Study
|
THE EFFICACY OF SHANKHADRAV IN THE MANAGEMENT OF MOOTRASHMARI WITH SPECIAL REFERENCE TO UROLITHIASIS A RANDOMIZED CONTROLLED TRIAL |
| 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 Vilas Eknath Koli |
| Designation |
2nd Year PG Scholar |
| Affiliation |
R .T Ayurved Mahavidyalaya , Akola |
| Address |
Radhakisan Toahniwal Ayurved Mahavidyalay Akola Shalyatantra Department OPD no 7
Akola
MAHARASHTRA
444005
India |
| Phone |
9284733526 |
| Fax |
|
| Email |
ayurvedant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrakant Dhanokar |
| Designation |
Asst. Prof. Department of Shalya Tantra |
| Affiliation |
R .T Ayurved Mahavidyalaya , Akola |
| Address |
Radhakisan Toshniwal Ayurved Mahavidyalaya Akola, Maharashtra 444005
Akola
MAHARASHTRA
444005
India
Akola
MAHARASHTRA
444005
India |
| Phone |
9975053354 |
| Fax |
|
| Email |
jagdishdhanokar2010@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrakant Dhanokar |
| Designation |
Asst. Prof. Department of Shalya Tantra |
| Affiliation |
R .T Ayurved Mahavidyalaya , Akola |
| Address |
Nibandhe Plots, Akola 444005
Radhakisan Toshniwal Ayurved Mahavidyalaya, Kediya Plots, Jatharpeth
Road, Akola, Maharashtra 444005
Akola
MAHARASHTRA
444005
India
Akola
MAHARASHTRA
444005
India |
| Phone |
9975053354 |
| Fax |
|
| Email |
jagdishdhanokar2010@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Radhakisan Toshniwal Ayurved Hospital opd no 7,station road Akola, Maharashtra 444005
india
|
|
|
Primary Sponsor
|
| Name |
Dr Vilas Eknath Koli |
| Address |
Radhakisan Toshniwal Ayurved Mahavidyalaya, Kediya Plots,
Jatharpeth Road, Akola, Maharashtra 444005
|
| 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 Vilas Eknath Koli |
Radhakisan Toshniwal Ayurved Mahavidyalaya and Hospital, Akola |
New Radhakisan
Plots, Railway Station
Road, Akola,
Maharashtra 444001,
At Shalya Tantra
department, OPD
Number 7.
Akola
MAHARASHTRA
Akola
MAHARASHTRA |
09284733526
ayurvedant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Radhakisan Toshniwal Ayurved Mahavidyalaya, Akola, Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N23||Unspecified renal colic. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHANKHADRAVA, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Dravaka, Dose: 6(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Guggulu, Reference: Bharat Bhaishjya Ratnakar vol 2, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient presenting with sign and symptoms of Mootrashmari.
2. Patients with size of calculus from 5mm to 12 mm.
3. Patients having calculus at Kidney, Ureter, Bladder.
4. Patients between age 18 to 60 years.
5. Patients willing to participate in clinical trial with written consent.
|
|
| ExclusionCriteria |
| Details |
Pregnancy / Lactation
Patients not willing to participate in trial.
Patients suffering from associated Urolithiasis with following disease will be
excluded.
Immunocompromised patient.
Diabetic patients.
Renal failure, congenital disorders like ectopic kidney, horse shoe kidney,
stricture at Uretero Vesical & Uretero Pelvic junction, neoplasm.
Patients having severe hydronephrosis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in size of urinary calculi with treatment. |
Up to 45days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Signs and symptoms of Urolithiasis will improve with treatment. |
Up to 45 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2025 |
| 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 - NO
|
|
Brief Summary
|
To study the efficacy of Shankhdrava in the management of Mootrashmari is the main objective of the study. It is a comparative study design to access the efficacy of shankhrava for trial group and Gokshuradi guggulu for control group.
Total 60 patients fulfilling the diagnostic criteria which are based on sign and symptoms of Urolithiasis Examination will be selected for study. Duration of total study 18 months. Duration of trial is 45days with follow up period of 45days. Patient will be selected form OPD and IPD of our own institute . On the basis of 18 to 60 year age , subject, irrespective of religion, gender and occupation. |