| CTRI Number |
CTRI/2025/12/099198 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on the Effect of Homoeopathic Medicines on Pain and Daily Life in People with Ankylosing Spondylitis |
|
Scientific Title of Study
|
Effect of Individualised Homoeopathic Medicine in 50 Millesimal Potency in the Management of Ankylosing Spondylitis and Its Impact on Quality of Life – A Prospective Open-Label 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 Gone Maniprasad |
| Designation |
Post GraduateTrainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Department of Organon of Medicine OPD no 14
Block GE Sector III
Salt Lake City
Kolkata 700106
West Bengal India
National Institute of Homoeopathy
Department of Organon of Medicine OPD no 14
Block GE Sector III
Salt Lake City
Kolkata 700106
West Bengal India
Kolkata
WEST BENGAL
700106
India |
| Phone |
9502487797 |
| Fax |
|
| Email |
maniprasadnih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gone Maniprasad |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Department of Organon of Medicine OPD no 14
Block GE Sector III
Salt Lake City
Kolkata 700106
West Bengal India
National Institute of Homoeopathy
Department of Organon of Medicine OPD no 14
Block GE Sector III
Salt Lake City
Kolkata 700106
West Bengal India
Kolkata
WEST BENGAL
700106
India |
| Phone |
9502487797 |
| Fax |
|
| Email |
maniprasadnih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Subhas Singh |
| Designation |
Professor and Head of Department Organon of Medicine |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Department of Organon of Medicine OPD no 14
Block GE Sector III
Salt Lake City
Kolkata 700106
West Bengal India
National Institute of Homoeopathy
Department of Organon of Medicine OPD no 14
Block GE Sector III
Salt Lake City
Kolkata 700106
West Bengal India
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830644223 |
| Fax |
|
| Email |
drssubhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE Sector III
Salt Lake City
Kolkata 700106
West Bengal India |
| Type of Sponsor |
Government 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 |
| DrGone Maniprasad |
National Institute of Homoeopathy |
National Institute of Homoeopathy
Department of Organon of Medicine OPD no 14
Block GE Sector III
Salt Lake City
Kolkata 700106
West Bengal India
Kolkata
WEST BENGAL |
9502487797
maniprasadnih@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M45||Ankylosing spondylitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVIDUALISED HOMOEOPATHIC MEDICINE |
This study aims to evaluate the effect of individualized homoeopathic medicines administered in 50-millesimal (LM) potency on disease activity and quality of life in patients with ankylosing spondylitis. The study will observe changes in pain, stiffness, functional ability, and quality of life over a defined 6 months of follow-up period. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Cases fulfilling the diagnostic criteria for Ankylosing Spondylitis (ICD 10 M45)
according to the ASAS classification criteria for axial spondyloarthritis
Patients aged 18 to 45 years
Patients of all sexes religions and socio-economic backgrounds
Patients who have not taken any conventional treatment for AS in the last 4 weeks
Patients who are willing to give consent
Patients who can read or understand either English Hindi or Bengali |
|
| ExclusionCriteria |
| Details |
Patients diagnosed with life-threatening diseases, uncontrolled systemic illnesses,
immunocompromised states psychiatric disorders or malignancy
Patients unwilling to undergo required investigations if needed
Patients currently on NSAIDs DMARDs or biological therapy for AS
Pregnant women and lactating mothers
Patients with a history of substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bath Ankylosing Spondylitis Disease Activity Index BASDAI
scores
|
baseline to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ankylosing Spondylitis Quality of Life questionnaire |
baseline to 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/12/2025 |
| 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="1"
Months="6"
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
|
This is a single arm prospective interventional open label non randomized clinical study conducted over a period of 18 months. Participants will be adults aged 18 to 45 years diagnosed with Ankylosing Spondylitis according to the Assessment of SpondyloArthritis International Society ASAS classification criteria. Eligible participants will have active disease symptoms including chronic inflammatory back pain and morning stiffness with impaired functional status and reduced quality of life as assessed by validated clinical indices. Participants must be able to provide informed consent understand the study language and comply with study procedures. Participants will be excluded if they have other inflammatory or autoimmune arthritides severe systemic illness spinal trauma or surgery pregnancy or lactation serious psychiatric disorders or if they are receiving long term immunosuppressive or biological therapy. Patients unwilling or unable to adhere to follow up schedules will also be excluded.
All eligible participants will receive individualized homoeopathic medicines selected based on the totality of symptoms and constitutional characteristics. Medicines will be prescribed in fifty millesimal LM potency sourced from GMP certified manufacturers with dosage and repetition individualized according to patient response. Treatment outcomes will be assessed at baseline to six months using BASDAI and ASQoL scores to evaluate changes in disease activity and quality of life. |