| CTRI Number |
CTRI/2025/12/099121 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoepathic Management of Kidney Stones with Bryophyllum Mothertincture |
|
Scientific Title of Study
|
Single – Arm Open Label Interventional Study Of Bryophyllum Pinnatum Mothertincture In Treating The Patients With Nephrolithiasis |
| 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 Chetti Soumya |
| Designation |
PG SCHOLAR |
| Affiliation |
JIMS Homeopathic Medical College and Hospital |
| Address |
OPD 6
DEPARTMENT OF PRACTICE OF MEDICINE
JIMS HOMOEOPATHIC MEDICAL COLEGE AND HOSPITAL SRIRAMNAGAR MUCHINTAL HYDERABAD TELANGANA INDIA 509325
Hyderabad TELANGANA 509325 India |
| Phone |
8309409658 |
| Fax |
04023470444 |
| Email |
chettisoumya99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nimai chandra Dhole |
| Designation |
Professor |
| Affiliation |
Jims homeopathic medical college and hospital |
| Address |
OPD 6
DEPARTMENT OF PRACTICE OF MEDICINE
JIMS HOMOEOPATHIC MEDICAL COLEGE AND HOSPITAL SRIRAMNAGAR MUCHINTAL HYDERABAD TELANGANA INDIA 509325
Hyderabad TELANGANA 509325 India |
| Phone |
9448255103 |
| Fax |
04023470444 |
| Email |
drnimaichandradhole@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Chetti Soumya |
| Designation |
PG SCHOLAR |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD 6
DEPARTMENT OF PRACTICE OF MEDICINE
JIMS HOMOEOPATHIC MEDICAL COLEGE AND HOSPITAL SRIRAMNAGAR MUCHINTAL HYDERABAD TELANGANA INDIA 509325
Hyderabad TELANGANA 509325 India |
| Phone |
8309409658 |
| Fax |
04023470444 |
| Email |
chettisoumya99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIMS Homoeopathic medical college and hospital |
| Address |
OPD 6
DEPARTMENT OF PRACTICE OF MEDICINE
JIMS HOMOEOPATHIC MEDICAL COLEGE AND HOSPITAL SRIRAMNAGAR MUCHINTAL HYDERABAD TELANGANA INDIA 509325 |
| 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 Chetti Soumya |
JIMS Homoepathic Medical College and Hospital |
OPD 6
DEPARTMENT OF PRACTICE OF MEDICINE
JIMS HOMOEOPATHIC MEDICAL COLEGE AND HOSPITAL SRIRAMNAGAR MUCHINTAL HYDERABAD TELANGANA INDIA 509325 Hyderabad TELANGANA |
8309409658 04023470444 chettisoumya99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIMS Homoeopathic Medical College and Hospital |
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 |
| Intervention |
Bryophyllum Pinnatum Mother tincture |
10 drops of Bryophyllum Pinnatum mother tincture in 15 ml of distilled water thrice a day for 1 week |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients diagnosed with Nephrolithiasis through Ultrasonography[abdomen and pelvis]
patients with non obstructive renal calculi size upto 8mm and Hydronephrosis with normal creatinine level |
|
| ExclusionCriteria |
| Details |
presence of acute kidney failure urosepsis chronic kidney disease pyelonephritis
patients with history of above mentioned kidney pathologies and severe co morbidities are excluded
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in number of calculi of Kidney after administration of Bryophyllum Pinnatum Mother tincture in Patients with Nephrolithiasis |
Baseline and for every 1 month for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in number of calculi of Kideny after Bryophyllum Pinnatum Mother tincture in patients with Nephroloithiasis |
Baseline and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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 Applicable |
| 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
|
Nephrolithiasis (kidney stone disease) is a common global health problem with rising incidence, recurrence, and economic burden. Conventional treatments such as analgesics, hydration therapy, lithotripsy, and surgery often have side effects and high recurrence rates, creating a need for safer and more effective therapeutic approaches.Bryophyllum pinnatum, known for its traditional use in kidney stones, contains citric, malic, and isocitric acids, which help dissolve or prevent the formation of calcium-based stones through calcium chelation and antilithogenic action. Although many homeopathic medicines are used for nephrolithiasis, focused clinical evidence on Bryophyllum mother tincture alone is limited.
This study is designed as a single-arm, open-label interventional clinical study to evaluate the effect of Bryophyllum pinnatum mother tincture in patients aged 18–60 years with ultrasonography-confirmed nephrolithiasis. Thirty patients will be selected (after accounting for dropouts) from OPD/IPD settings of JIMS Homoeopathic Medical College.Patients will receive Bryophyllum Mother tincture , 10 drops in 15 ml water, thrice daily for one week, followed by regular follow-ups over three months. USG and urinalysis will assess changes.
Primary outcome is reduction in number and size of renal calculi. and Secondary outcomes is Reduction in frequency of renal colic and improvement in symptoms.Data will be analyzed using appropriate statistics (McNemar’s test), following ethical standards. The study aims to provide clinical evidence on the effectiveness of Bryophyllum mother tincture in treating nephrolithiasis. |