| CTRI Number |
CTRI/2026/01/101487 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
ANALYSING THE BLOOD PLASMA SERUM OF THE PATIENTS IN THE MEDICINAL GROUP AS WELL AS IN PLACEBO CONTROL GROUP BEFORE AND AFTER GIVING THE INDIVIDUALISED HOMOEOPATHIC REMEDY AND PLACEBO RESPECTIVELY, IN THE PATIENTS OF OSTEOARTHRITIS OF KNEE AND ANALYSING THROUGH WOMAC SCALE.
|
|
Scientific Title of Study
|
A RANDOMIZED PLACEBO CONTROLLED SINGLE BLIND PARALLEL
TRIAL WITH PRE AND POST INTERVENTION BLOOD PLASMA
ANALYSIS USING UV SPECTROPHOTOMETRY ALONGWITH WOMAC
SCALE IN OSTEOARTHRITIS OF KNEE |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchi Pankajbhai Mehta |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute Of Homoeopathy And Research |
| Address |
Parul Institute Of Homoeopathy And Research
At. Ishwarpura, PO. Limda,
TA. Waghodia, DI. Vadodara Floor No.:3, Room No.:404, Department of Homoeopathic Pharmacy
At. Ishwarpura, PO. Limda,
TA. Waghodia, DI. Vadodara
Parul Institute Of Homoeopathy And Research
At. Ishwarpura, PO. Limda,
TA. Waghodia, DI. Vadodara – 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7984399726 |
| Fax |
|
| Email |
ruchimehta2461999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh Reddy |
| Designation |
HOD AND PROFFESOR |
| Affiliation |
Parul Institute Of Homoeopathy And Research |
| Address |
Parul Institute Of Homoeopathy And Research
Floor No.:3, Room No.:404, Department of Homoeopathic Pharmacy At. Ishwarpura, PO. Limda,
TA. Waghodia, DI. Vadodara
Parul Institute Of Homoeopathy And Research At. Ishwarpura, PO. Limda,
TA. Waghodia, DI. Vadodara – 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9663875835 |
| Fax |
|
| Email |
santosh.hudgikar28869@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi Pankajbhai Mehta |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute Of Homoeopathy And Research |
| Address |
Parul Institute Of Homoeopathy And Research Floor No.:3, Room No.:404, Department of Homoeopathic Pharmacy
At. Ishwarpura, PO. Limda,
TA. Waghodia, DI. Vadodara
Parul Institute Of Homoeopathy And Research
At. Ishwarpura, PO. Limda,
TA. Waghodia, DI. Vadodara – 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7984399726 |
| Fax |
|
| Email |
ruchimehta2461999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Homoeopathy And Research
|
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Homoeopathy And Research |
| Address |
Parul Institute Of Homoeopathy And Research
At. Ishwarpura, PO. Limda,
TA. Waghodia, DI. Vadodara – 391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| RUCHI PANKAJBHAI MEHTA |
PARUL INSTITUTE OF HOMOEOPATHY AND RESEARCH
At. ISHWARPURA, PO. LIMDA,
TA. WAGHODIA, DI. VADODARA – 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Pankajbhai Mehta |
Parul Institute Of Homoeopathy And Research |
Floor No.: 3, Room No.: 404, Department of Homoeopathic Pharmacy
At. Ishwarpura, PO. Limda,
TA. Waghodia, DI. Vadodara – 391760
Vadodara
GUJARAT |
7984399726
ruchimehta2461999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVIDUALISED HOMOEOPATHIC MEDICINE |
The complete case-taking of each patient will be carried out as per the prescribed proforma. With the assistance of a pathology laboratory, blood samples will be collected intravenously and centrifuged to obtain blood plasma/serum. The extracted plasma will then be placed in a cuvette of the UV–Visible spectrophotometer, and absorbance will be recorded within the wavelength range of 400–800 nm. The results will be obtained in the form of absorbance graphs. Patients will be selected randomly from the list of both groups. Participants in the intervention group will be prescribed an individualised homoeopathic remedy based on the principle of symptom similarity. The medicine will be administered orally in the form of 30 pills. Follow-up of the patients will be conducted weekly for a duration of three months. |
| Comparator Agent |
PLACEBO |
The complete case-taking of the patients will be carried out as per the prescribed proforma. With the assistance of a pathology laboratory, blood samples will be collected intravenously and centrifuged to obtain blood plasma/serum. The obtained plasma will be placed in a cuvette of the UV–Visible spectrophotometer, and absorbance will be recorded within the wavelength range of 400–800 nm. The results will be expressed in the form of absorbance graphs.Patients will be selected randomly from the list of both groups. Participants in the placebo control group will be administered a placebo. The medication will be given through the oral route in the form of 30 pills. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with osteoarthritis (OA) according to ICD-10.
Moderate to severe symptoms as measured by the WOMAC scale.
Willingness to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with degenerative changes in osteoarthritis (Grade 3 and Grade 4).
Patients suffering from other pathological diseases.
Pregnant or breastfeeding women.
Participation in another clinical trial within the last 30 days.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the difference in blood plasma samples of both groups using a UV–Visible spectrophotometer and to understand the observed differences. |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the change in patient’s complaints in both the groups, through regular follow-ups
and WOMAC scale.
|
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/03/2026 |
| 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
|
This study is designed as a randomized, placebo-controlled, single-blind, parallel clinical trial to evaluate the effect of individualized homoeopathic treatment in patients with knee osteoarthritis. Participants will be randomly allocated into intervention and placebo control groups. Comprehensive case-taking will be carried out as per standard proforma, followed by baseline assessment using the WOMAC scale to evaluate pain, stiffness, and physical function. Blood samples will be collected before and after the intervention and processed to obtain blood plasma. UV–Visible spectrophotometric analysis will be performed on plasma samples to record absorbance patterns within a defined wavelength range. Post-intervention assessments will be conducted after a fixed treatment duration to observe changes. The WOMAC scale will be re-evaluated at regular follow-up intervals to assess clinical improvement. The placebo group will receive indistinguishable inert pills to ensure blinding. This design allows for objective biochemical evaluation along with subjective clinical assessment. The study aims to correlate changes in UV spectrophotometric absorbance with clinical outcomes. The purpose of the study is to explore the potential role of individualized homoeopathy in knee osteoarthritis and to generate scientific evidence through measurable laboratory parameters. |