| CTRI Number |
CTRI/2025/09/095491 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Managing Swelling (Lymphedema) in Patients: Homoeopathy Compared with Standard Treatment |
|
Scientific Title of Study
|
Comparative study of individualised Homoeopathic medicines with standard line of treatment in management of Lymphedema |
| Trial Acronym |
LYM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nayana Parmar |
| Designation |
PhD Scholar |
| Affiliation |
Dr.D.Y.Patil Homoeopathic Medical College and research centre,Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research centre,sant tukaram nagar,pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9850587928 |
| Fax |
|
| Email |
pc.nayanaparmar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nayana Parmar |
| Designation |
PhD Scholar |
| Affiliation |
Dr.D.Y.Patil Homoeopathic Medical College and research centre,Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research centre,sant tukaram nagar,pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9850587928 |
| Fax |
|
| Email |
pc.nayanaparmar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDharmendra Sharma |
| Designation |
Principal |
| Affiliation |
Dr.D.Y.Patil Homoeopathic Medical College and research centre,Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research centre,sant tukaram nagar,pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9422330045 |
| Fax |
|
| Email |
Principal.homoeopathy@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil Homoeopathic Medical College and research centre,Pune |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrDharmendra Sharma |
Dr.D.Y.Patil Homoeopathic Medical Medical College and Hospital |
Dr.D.Y.Patil Homoeopathic Medical Medical College and Hospital,Sant tukaram nagar,pimpri
Pune
MAHARASHTRA |
9422330045
Principal.homoeopathy@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.Y.Patil homoeopathic medical college and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I890||Lymphedema, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
complete decongestive therapy |
complete decongestive therapy once a day for 12 weeks |
| Intervention |
Individualised Homoeopathic Medicine |
Individualised Homoeopathic Medicine
Dose: Depending on the laws of susceptibility, it will be Individualized dosage (from single dose to multiple doses).
orally in water dilution
Duration 6-12 weeks as per symptoms |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed lymphedema (primary or secondary) by medical history, physical examination, and imaging studies.
Severity: Mild, moderate, or severe lymphedema (Stage 0-3)
Patients presenting with chronic or episodic Lymphedema symptoms such as Swelling, pain, heaviness, or limited mobility in affected limb
Ability to provide informed consent and compley with the study |
|
| ExclusionCriteria |
| Details |
Pregnancy or lactation
Severe systemic diseases (e.g., heart failure, severe kidney disease, severe liver disease)
Limb amputation or severe trauma to affected limb
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the limb circumference from baseline to end of treatment at 12 weeks measured at standardised anatomical landmarks. |
Baseline ,4 weeks ,8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life , change in disease specific quality of life(LYMQOL)questionnaire |
Change in quality of life from baseline to end of treatment at 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
03/11/2025 |
| 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="3"
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
|
This study will assess the effectiveness of individualised Homoeopathic medicines and standard treatment protocol consisting of complete decongestive therapy in management of Lymphedema.Adults between 18 to 70 years with primary or secondary Lymphedema will be included in the study.The primary outcome is change in limb circumference in 12 weeks .Secondary-outcomes include quality of life and function of limbs.The study aims to determine the potential role of individualised Homoeopathic medicines as an adjuvant to Lymphedema management . |