| CTRI Number |
CTRI/2022/11/047674 [Registered on: 25/11/2022] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of urinary stone with Ayurvedic Calcirex capsule |
|
Scientific Title of Study
|
A single group pre and post designed clinical study to determine the effectiveness of Calcirex capsule in the patients of urinary stone. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manishkumar Patel |
| Designation |
Professor |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa,
J. S. Ayurved Mahavidyalaya,
College Road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manishkumar Patel |
| Designation |
Professor |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa,
J. S. Ayurved Mahavidyalaya,
College Road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Manishkumar Patel |
| Designation |
Professor |
| Affiliation |
J S Ayurved Mahavidyalaya |
| Address |
Department of Kayachikitsa,
J. S. Ayurved Mahavidyalaya,
College Road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Source of Monetary or Material Support
Modification(s)
|
| P D Patel Ayurveda Hospital, Nadiad |
| The Punarvasu (Petlad Mahal Arogya Mandal Pharmacy), Nadiad |
|
|
Primary Sponsor
|
| Name |
The Punarvasu (Petlad Mahal Arogya Mandal Pharmacy) |
| Address |
Petlad Road,
Nadiad - 387002 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Manish Patel |
P D Patel Ayurveda Hospital |
Room no. 102, OPD department of Kayachikitsa, J S Ayurved Mahavidyalaya Campus,
College Road, Nadiad
Kheda
GUJARAT |
9979589865
manishayu97@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research of J S Ayurved Mahavidyalaya, Nadiad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Calcirex, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: No any |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having any one or more of the following criteria will be included for the study.
a. Classical pain in the both, renal angle and loin region, radiating (referring)
towards groin.
b. Burning micturition with or without pain.
c. Haematuria.
d. Crystal uria.
e. Nausea or Vomiting
f. USG evidence of the stone. |
|
| ExclusionCriteria |
| Details |
a. Cases of urinary stone with acute severe unbearable abdominal pain.
b. More than 8 mm size of calculus.
c. Cases with moderate/severe hydronephrosis, uremia, recurrent urinary tract
infections (other than calculi), acute retention of urine for more than 24 hours,
hyper parathyroidism, gross developmental defects or structural abnormality of
kidney, other systemic diseases like cardiovascular, endocrinal diseases or
systemic infections, kidney function impairment, stag horn calculus. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in following signs and symptoms -
1. Pain
2. Burning micturition,
3. Frequency of micturition
4. Hematuria |
baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in size and number of calculus |
base line and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
None yet |
|
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 - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [manishayu97@yahoo.com].
- For how long will this data be available start date provided 01-12-2022 and end date provided 31-12-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Participants (patients) who fulfill the inclusion criteria will be selected from the outpatient and in-patient department of P D Patel Ayurved Hospital attached with J S Ayurved Mahavidyalaya after taking their consent. Diagnostic procedure: Patients having one or more of the signs and symptoms of urinary stone i.e. pain in abdomen or loin, increased frequency of urine, burning micturition, hematuria and nausea or vomiting will be examined and screened for urine routine and microscopic exam. Presence of crystals, casts, RBC, epithelial cells in urine will be noted. However, confirmation of diagnosis will be on the base of ultrasound scan reports suggesting the presence of stone in urinary tract. Intervention and dosage of drugs: Calcirex capsule will be an intervention of the study. Each capsule is of 500 mg which contains following ingredients. Extract of Bergenia ciliate (rhizome of Pashanabheda) - 100 mg Extract of Crataeva nurvala (stembark of Varuna) - 100 mg Extract of Boerhavia diffusa (root of Punarnava) - 60 mg Extract of Tribulus terrestris (fruit of Gokshura) - 60 mg Hazaul Yahud pishti (Lapis Juidaicus) -100 mg Shuddha Shilajit (Asphaltum punja- bianum) - 50 mg Hordeum vulgare (Sarjikakshara) - 30 mg Two capsules of Calcirex will be given three times in a day with warm water and after the meal. Diet for all the patients: Mung, mung beans soup, rice, gram flour chapati, vegetables which are easy to digest will be recommended to the patients. Sour tasty, fermented food items and vegetables which contain small seeds i.e. tomatoes, chilies, lady finger will not be allowed. Duration of treatment: Main assessment period will be after the 4 weeks of the treatment. During the follow-up period, patients will be instructed to continue all the oral medicaments and diet as per the mentioned schedule. Assessment of patients: Patients will be assessed on the basis of relief in signsymptoms, other invasive investigation and findings of laboratory on the basis of specially designed research Performa through scoring pattern. Outcome measures: Assessment of therapy was done according to the relief observed in the sign and symptoms with the help of following scoring pattern. The details of the scores adopted for the chief signs and symptoms (before and after treatment) in the present study are as follows – 1. Pain No pain - 0 Bearable pain (1 or 2 times during study period) - 1 Bearable pain occasionally (average 2 to 3 times /week) - 2 Bearable pain Everyday – 3 2. Burning micturition No burning micturition – 0 Burning micturition (1 or 2 times during study period) - 1 Regular burning micturition (average 2 to 3 times /week) - 2 Regular burning micturition everyday - 3 3. Haematuria No haematuria - 0 Smoky black coloured urine - 1 Bright red coloured urine – 2 4. Frequency of micturition (in 24 hours) Up to 6 times - 0 7-9 times - 1 10-12 times - 2 >12 times – 3 5. Size of stone (with the help of USG) 6. Number of stones (with the help of USG)
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