| CTRI Number |
CTRI/2023/02/049541 [Registered on: 08/02/2023] Trial Registered Prospectively |
| Last Modified On: |
02/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Preparation of herbal decoction for urinary stone |
|
Scientific Title of Study
|
Evaluation of efficacy of shunthyadi kwath in urolithiasis (Reverse pharmacology approach) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anita Kumari |
| Designation |
phd Scholar |
| Affiliation |
Mahatama Gandhi Ayurved College Hospital and Resarch Centre |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre department of Rasashastra and Bhaishajya kalpana salod hirapur Wardha Datta Meghe Institue of Medical Science Swangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7404205709 |
| Fax |
|
| Email |
dr.yadav2508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Kumari |
| Designation |
phd Scholar |
| Affiliation |
Mahatama Gandhi Ayurved College Hospital and Resarch Centre |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre department of Rasashastra and Bhaishajya kalpana salod hirapur Wardha Datta Meghe Institue of Medical Science Swangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7404205709 |
| Fax |
|
| Email |
dr.yadav2508@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Kumari |
| Designation |
phd Scholar |
| Affiliation |
Mahatama Gandhi Ayurved College Hospital and Resarch Centre |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre department of Rasashastra and Bhaishajya kalpana salod hirapur Wardha Datta Meghe Institue of Medical Science Swangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7404205709 |
| Fax |
|
| Email |
dr.yadav2508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma gandhi ayurved college hospital and research center salod h wardha |
|
|
Primary Sponsor
|
| Name |
Mahatama Gandhi Ayurved College Hospital and Resarch Center Salod Wardha |
| Address |
Mahatama Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Swangi Wardha 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Anita Wanjari |
Mahatma gandhi ayurved college hospital and research center salod wardha |
Mahatma Gandhi Ayurved College and Hospital, Dept of Rashashtra evam Bhaishjya Kalpana, Salod Hirapur Sawangi, Wardha 442001
Wardha
MAHARASHTRA |
8329030492
anitawanjari7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Center Institutional ethics committee Salod Wardha 442001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers patients of age 15-60 years |
| Patients |
(1) ICD-10 Condition:B||Imaging. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi Kwath, Reference: Vaidya Chintamani, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Cystone, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age of 15 to 60 Years irrespective of sex, race, occupation and socio-economical status.
Patient Presented with general clinical features of urolithiasis as per classic and modern literature. Stone visible though USG |
|
| ExclusionCriteria |
| Details |
Patients below 15 years and above 60 years.Calculi measuring more than 8 mm in size. Severe haematuria. Patients with immediate surgical requirement and acute retention of urine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| If pharmaceutical preparation of herbal compound is found significant then it will be used as anti-lithiasis drug. |
Follow –up in every 15 days for 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| If this study is successful then this data will be used in another clinical study for invention of other Ayurvedic herbal compound which will be beneficial in treating urinary stone |
12 Weeks |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The participants will be informed about the study protocol.Willing participants will be randomaly selected as per inclusive and exclusive criteria.Prior to study approval will be taken from IEC,MGACHRC,Salod (H) Wardha and CTRI registration will be done.Total 60 participants will be taken for study and divided in two groups (30 participants in each group).Each participants will be assesses and CT KUB done before and after treatment.In one group tab cystone 500mg will be given as standard drug and in second group shunthyadi kwath 48 ml will given as test drug for a period of 12 weeks.After completion of the treatment for 12 weeks each participants will be assessed with Ayurvedic as well as Modern parameters. Those participants who left treatment in between will be drop out from study. |