| CTRI Number |
CTRI/2026/02/103164 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Homoeopathic Medicine Valeriana officinalis and Individualised Homoeopathic Medicine in the treatment of Plantar Fasciitis with Calcaneal Spur |
|
Scientific Title of Study
|
Assessing the effectiveness of Valeriana officinalis and Individualised Homoeopathic Medicine in the treatment of Plantar Fasciitis with Calcaneal Spur-A Comparative study |
| 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 Dhanyashree B V |
| Designation |
PG Student |
| Affiliation |
Government Homoeopathic Medical College and Hospital |
| Address |
Government Homoeopathic Medical College and Hospital
Dr Siddhaiah Puranik Road
Basaveshwara Nagar
Bangalore 560079
Dept of HMM
Ground floor Room no 22
Bangalore
KARNATAKA
560079
India |
| Phone |
9731062265 |
| Fax |
|
| Email |
dhanyashreebv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Krishna V |
| Designation |
Professor |
| Affiliation |
Government Homoeopathic Medical College and Hospital |
| Address |
Government Homoeopathic Medical College and Hospital
Dr Siddhaiah Puranik Road
Basaveshwara Nagar
Bangalore 560079
Ground floor Room no 22
Bangalore
KARNATAKA
560079
India |
| Phone |
9731062265 |
| Fax |
|
| Email |
doc_vijaykrishna@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanyashree B V |
| Designation |
PG Student |
| Affiliation |
Government Homoeopathic Medical College and Hospital |
| Address |
Government Homoeopathic Medical College and Hospital
Dr Siddhaiah Puranik Road
Basaveshwara Nagar
Bangalore 560079
Dept of HMM
Ground floor Room no 22
Bangalore
KARNATAKA
560079
India |
| Phone |
9731062265 |
| Fax |
|
| Email |
dhanyashreebv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Dhanyashree B V |
| Address |
Government Homoeopathic Medical College and Hospital
Dr Siddhaiah Puranik Road
Basaveshwara Nagar
Bangalore 560079
Ground floor Room no 22 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Dhanyashree B V |
Government Homoeopathic Medical College and Hospital |
Government Homoeopathic Medical College and Hospital
Dr Siddhaiah Puranik Road
Basaveshwara Nagar
Bangalore 560079
Ground floor Room no 22
Bangalore
KARNATAKA |
9731062265
dhanyashreebv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M773||Calcaneal spur, (2) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualised Homoeopathic Medicine |
To assess the effectiveness of Individualised Homoeopathic Medicine in the treatment of Plantar fasciitis with Calcaneal spur
Dose and frequency depends upon susceptibility
administration oral |
| Intervention |
Valeriana officinalis |
To assess the effectiveness of Valeriana officinalis in the treatment of Plantar fasciitis with Calcaneal spur
Dose and frequency depends upon susceptibility
administration oral |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who are willing to participate as Volunteers and sign the written informed consent.
2. Subjects of age group 20-60 years of age.
3. Clinically and radiologically diagnosed new cases of plantar fasciitis with calcaneal spur.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are having inflammatory joint diseases like rheumatoid arthritis, osteoarthritis, gout.
2. Subjects with previous foot trauma, deformity, or dysfunction.
3. Pregnant women & Lactating mother. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms based on Foot Health Status Questionnaire |
By the end of 3months
Every 15days follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of life
Reduction in symptoms of Plantar fasciitis |
By the end of 6 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)
|
20/02/2026 |
| 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="6"
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
|
NEED FOR THE STUDY
Plantar fasciitis is a prevalent and one of the most common musculoskeletal conditions affecting the lower limb, which arises from the degenerative irritation of the plantar fascia that originates at the medial calcaneal tuberosity of the heel and involves the adjacent fascial tissues
Plantar calcaneal spur is described as bony outgrowths that develops just anterior to the medial process of the calcaneal tuberosity
The two conditions often share risk factors like aging and obesity, suggesting a possible association. High rates of calcaneal spurs have been reported among those suffering from plantar fasciitis
An estimated 10 percentage of the general population is affected, with around 83 percentage of these individuals being physically active adults between the ages of 25 and 65. Plantar fasciitis typically occurs between the ages of 40 and 60 and is responsible for around 15 percentage of all foot related injuries in the general population, with no significant difference between genders. While it can affect both athletic and non athletic individuals, the condition is more frequently observed in runners. Epidemiological data suggest a higher prevalence among women and those with a body mass index exceeding 25 kg per m².
Plantar fasciitis results from repetitive strain leading to micro-tears in the plantar fascia. While it can arise from direct trauma, it is often associated with multiple contributing factors. Common predisposing conditions include flat feet, high arches, limited ankle dorsiflexion, and abnormal foot mechanics such as excessive pronation or supination. Additional risk factors include obesity, aging, prolonged weight bearing activities, occupations that involve long periods of standing, and thinning of the heel pad.
Valeriana officinalis is a homoeopathic remedy used for nerve sensitivity, muscle tension, and musculoskeletal disorders; however, a significant research gap exists regarding its clinical effectiveness in the treatment of plantar fasciitis with calcaneal spur.
Hence, this study is intended to assess the effectiveness of Valeriana officinalis in comparison to Individualized Homoeopathic Medicine in the treatment of plantar fasciitis with calcaneal spur.
RESEARCH QUESTION
Is there any difference in the effectiveness of Valeriana officinalis and Individualised Homoeopathic Medicine in the treatment of plantar fasciitis with calcaneal spur?
NULL HYPOTHESIS
There may not be significant difference in the effectiveness between Valeriana officinalis and Individualized Homoeopathic Medicine in the treatment of plantar fasciitis with calcaneal spur
ALTERNATIVE HYPOTHESIS
There may be significant difference in the effectiveness between Valeriana officinalis and Individualized Homoeopathic Medicine in the treatment of Plantar fasciitis with calcaneal spur |