| CTRI Number |
CTRI/2023/02/049695 [Registered on: 14/02/2023] Trial Registered Prospectively |
| Last Modified On: |
13/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY OF SAGALANOI CHOORANAM IN THE MANAGEMENT OF KALLADAIPPU (RENAL CALCULUS) |
|
Scientific Title of Study
|
AN OPEN CLINICAL TRIAL TO EVALUATE THE
EFFECTIVENESS OF SAGALANOI CHOORANAM IN THE
MANAGEMENT OF KALLADAIPPU (RENAL CALCULUS ) AMONG
OUT-PATIENTS ATTENDING AYOTHIDOSS PANDITHAR HOSPITAL,
NATIONAL INSTITUTE OF SIDDHA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N A Bharathi |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072549689 |
| Fax |
|
| Email |
cadbury156@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Associate Professor |
| Affiliation |
National institute of siddha |
| Address |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N A Bharathi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072549689 |
| Fax |
|
| Email |
cadbury156@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoaa Pandithar Hospital,
National Institute of Siddha,
Tmabaram Sanatorium,
kancheepuram,
chennai 47 |
|
|
Primary Sponsor
|
| Name |
National institute of siddha |
| Address |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 N A Bharathi |
Ayothidoss Pandithar Hospital |
Room no 7/8
Department of maruthuvam
National institute of siddha
Tambaram sanatorium
kancheepuram
chennai
Kancheepuram
TAMIL NADU |
8072549689
cadbury156@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sagalanoi Chooranam |
1.3gms bd warm water for 48 days |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with renal calculus detected on USG Abdomen, Stone size: <9mm&≥4mm
2. Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can opt out of the trial of his/her own conscious discretion.
3. Patient who are willing to take Ultrasonography investigation (USG - Abdomen/ CT KUB) and provide
blood sample for lab investigation. |
|
| ExclusionCriteria |
| Details |
1. K/H/O Malignancy
2. Pregnant women and planning to be pregnant within three months
3. Lactating mother
4. K/H/O Chronic kidney disease
5. Uncontrolled systemic illness
6. K/C/O Ischemic heart disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Assesment by clearance or reduction in the size of the renal calculi in USG
ABDOMEN / KUB after treatment |
2MONTHS - SCREENING
2MONTHS - PATIENT ENROLLMENT
2MONTHS - OUTCOME ASSESSMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 |
|
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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Noy yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION:
This is an open clinical trial to evaluate the effectiveness of SAGALANOI CHOORANAM in
the management of RENAL CALCULI (Kalladaippu) through USG KUB before and after
treatment Renal calculi occurs when solutes crystallize out of urine to form stones. Urolithiasis
may occur due to anatomic features leading to urinary stasis, low urine volume, dietary factors
(e.g., high oxalate or high sodium), urinary tract infections, systemic acidosis, medications.
The most common cause of renal stone disease is inadequate hydration and subsequent low
urine volume. Researchers have concluded that about one in ten people will get a kidney stone
during their lifetime.
OUTCOME: Assesment by clearance or reduction in the size of the renal calculi in USG
ABDOMEN / KUB after treatment
MATERIALS AND METHODS:
A total of 10 patients diagnosed with kalladaippu ( Renal calculi) who are adults willing to
participate in the study by signing the consent form will be enrolled in the study . Patients with
Stone size > 9mm ,K/H/O Malignancy, Pregnant women and planning to be pregnant within
three months, Lactating mother, K/H/O Chronic kidney disease, Uncontrolled systemic illness
and patients not willing to sign the consent form will be excluded from the study. Assessment
will be done through USG Abdomen or CT KUB before and after the study
RESULTS AND DISCUSSION:
The results will be statistically analysed
KEYWORDS: Kalladaippu, Renal calculi, Sagalanoi chooranam |