| CTRI Number |
CTRI/2021/01/030273 [Registered on: 06/01/2021] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Shatavaryadi churna in the treatment of Mutrashmari |
|
Scientific Title of Study
|
A CLINICAL EVALUATION OF SHATAVARYADI CHURNA IN THE MANAGEMENT OF MUTRASHMARI WITH SPECIAL REFERENCE TO UROLITHIAISIS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anisha S Ashraf |
| Designation |
2nd Year PG Scholar Department of Shalya Tantra |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla
B M Road
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9495442136 |
| Fax |
|
| Email |
pg19163@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Narasimha Rao |
| Designation |
Principal & Professor |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla
B M Road
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Narasimha Rao |
| Designation |
Principal & Professor |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla
B M Road
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla
B M Road,
Hassan
Pin 573201 |
|
|
Primary Sponsor
|
| Name |
Dr Anisha S Ashraf |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla
B M Road,
Hassan
Pin 573201 |
| 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 Anisha S Ashraf |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
2nd Year PG Scholar
Department of Shalya Tantra
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
Thanniruhalla
B M Road
Hassan
Pin 573201
Hassan
KARNATAKA |
9495442136
pg19163@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: Mutrashmari, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Shatavaryadi Churna |
Shatavari
Gokshura
Kulatha
Punarnava
Varuna
Usheera
Equal parts mixed together 6gms churna orally twice daily after food for 21 days
Anupana Tamarind juice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Size of Ashmari less than 10 mm.
Age group between 18-70 years irrespective of gender, occupation, race and socio economic status.
Ureteric calculi, vesical calculi and renal calculi are included.
Multiple calculi less than or equal to 3
Those patients who are ready to undergo treatment as per protocol & who are ready to sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
Patients who are known case of severe systemic disorders like renal failure, tuberculosis, polycstic kidney and neoplasms.
Pregnant and lactating women.
Type I and Type II diabetes mellitus
HIV, HBsAg
Subjects with gouty arthritis
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Before and after treatment check for
Mehato Vedana in Nabhi Pradesha, Basti Pradesha, Seevani Pradesha, Mehana Pradesha (Pain while micturition)
Mutradaha (Burning micturition)
Sarudhira Mutrata (Haematuria)
Mutradhara Sanga (Obstructionto the flow of micturition/ frequency) |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Before and after treatment check for
Mehato Vedana in Nabhi Pradesha, Basti Pradesha, Seevani Pradesha, Mehana Pradesha (Pain while micturition)
Mutradaha (Burning micturition)
Sarudhira Mutrata (Haematuria)
Mutradhara Sanga (Obstructionto the flow of micturition/ frequency) |
21 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
06/01/2021 |
| Date of Study Completion (India) |
03/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
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 - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Published articles
- For how long will this data be available start date provided 18-01-2021 and end date provided 31-08-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
Mutrashmari which is one of the ashta mahagada is the most common disorders of mutravaha srotas. Though Ayurveda is effectively being used to manage it, it is the need of hour to develop a few evidence based formulations. Here six drugs are mixed together in equal quantity and 6 grams twice daily after food is given with tamarind juice for 21 days. The trial medicine contains the following drugs namely Shatavari, Gokshura, Kulattha, Punarnava, Varuna and Ushira. These drug are having Vedana Shamaka, Mutrala and Ashmari Bhedana actions. Hence the clinical study was undertaken to evaluate the effect of Shatavaryadi Churna over the subjective and objective parameters of Mutrashmari. OBJECTIVE : The main objective of the study is to evaluate the efficacy of Shatavaryadi Churna in the management of Mutrashamari with special reference to Urolithiasis. METHODOLOGY: Inerventional clinical study. Drug dosage: All the six drugs in Churna form will be mixed together and 6 grams twice daily after food for 21 days. Anupana : Amlika swarasa (Tamarind juice) Duration: Total duration of study was 28 days. Follow up: First follow up – 7th day Second follow up – 14th day Third follow up – 21st day After treatment follow up – 28th day RESULT : Shatavaryadi Churna shown significant reduction in pain abdomen, radiating pain, burning micturition, obstruction to the flow of urine, expulsion of calculi, reduction in number of calculi and reduction in size of calculi after the treatment. CONCLUSION : • The drug Shatavaryadi Churna shown significant improvement in both subjective and objective parameters. • Marked relief was obtained in pain abdomen, radiating pain, burning micturition and obstruction to the flow of micturition. • In current study, reduction in size and number of calculi had shown significant difference. • The drug has shown overall relief in symptoms of the Mutrashmari.
|