| CTRI Number |
CTRI/2026/04/107728 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“A Study to Compare the Effectiveness of Pareira Brava and Individualised Homoeopathic Treatment in Patients with Kidney Stones |
|
Scientific Title of Study
|
A comparative study on effectiveness of Pareira Brava and Individualised homoeopathic medicines in the treatment of Renal calculi |
| 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 Neeraja Mohan |
| Designation |
Post graduate student |
| Affiliation |
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
| Address |
Sreesanthi Mannamparambil
Karyamparambu Karukutty po
Ernakulam Department of Materia Medica
Government Homoeopathic Medical College
Iranimuttom
Thiruvananthapuram-695009 Thiruvananthapuram KERALA 683576 India |
| Phone |
8547203506 |
| Fax |
|
| Email |
neeraja.mohan90@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sreelatha S |
| Designation |
professor |
| Affiliation |
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
| Address |
Department of Materia Medica
Government Homoeopathic Medical College
Iranimuttom
Thiruvananthapuram-695009 Department of Materia Medica
Government Homoeopathic Medical College
Iranimuttom
Thiruvananthapuram-695009 Thiruvananthapuram KERALA 695009 India |
| Phone |
9447694037 |
| Fax |
|
| Email |
drsreelathas@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neeraja Mohan |
| Designation |
Post graduate student |
| Affiliation |
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
| Address |
Sreesanthi Mannamparambil
Karyamparambu Karukutty po
Ernakulam Department of Materia Medica
Government Homoeopathic Medical College
Iranimuttom
Thiruvananthapuram-695009
KERALA 683576 India |
| Phone |
8547203506 |
| Fax |
|
| Email |
neeraja.mohan90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
|
|
Primary Sponsor
|
| Name |
Dr Neeraja Mohan |
| Address |
PG Scholar
Department of Materia Medica
Government Homoeopathic Medical College
Iranimuttom Thiruvananthapuram-695009 |
| 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 Neeraja Mohan |
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
OP- 1
Materia medica department
Government Homoeopathic Medical College,Iranimuttom,
Thiruvananthapuram-695009 Thiruvananthapuram KERALA |
8547203506
neeraja.mohan90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
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 |
INDIVIDUALISED HOMOEOPATHIC MEDICINES |
Individualised homoeopathic medicines to Group B . |
| Intervention |
PAREIRA BRAVA 30 |
Pareira brava is administered orally, 3 pills thrice daily to group A with follow up of 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with Renal calculi confirmed by ultrasound abdomen and pelvis.
2.Males and females aged 20-59 years,regardless of socioeconomic status.
3.Stone size up to 8mm.
|
|
| ExclusionCriteria |
| Details |
1. Patients with complications like severe hydronephrosis.
2. Patients with severe systemic illnesses (e.g., hypertension, diabetes mellitus).
3. Patients with significant developmental or structural abnormalities of the renal tract.
4. Pregnant or lactating women.
5. Patients requiring emergency management |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study and compare the significant changes in the patient’s symptomatology with sonological findings and clinical symptoms in the management of renal calculi before and after the administration of Pareira brava and individualized homoeopathic medicines.
2. To study the effectiveness of Pareira brava in management of renal calculi. |
review in 2weeks
usg in 3months after baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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)
|
05/05/2026 |
| 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)
|
Not Yet Recruiting |
| 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
|
A Prospective quasi experimental study will be conducted at Government Homoeopathic Medical college, Thiruvananthapuram over a period of one year. 48 patients ( both male and female) aged between 20 - 59 years with renal calculi confirmed by ultrasound abdomen and pelvis upto the stone size 8mm is selected and divided into two groups. One group will be given (A) Pareira brava and the other group (B) Individualised homoeopathic medicines .The study aims to evaluate and compare the effectiveness of Pareira brava and individualised homoeopathic medicines in managing the renal calculi. |