| CTRI Number |
CTRI/2025/11/096760 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Chronic fatigue syndrome and homoeopathy |
|
Scientific Title of Study
|
Individualized homoeopathic treatment with consideration of accessory circumstances of chronic fatigue syndrome: An open label, single arm, clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1329-6273 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivangi Pandey |
| Designation |
Post Graduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Room no. 17 and 21, 265-266,APC ROAD KOLKATA-700009, West Bengal
Kolkata
WEST BENGAL
700009
India |
| Phone |
7003253248 |
| Fax |
|
| Email |
shivangii.pandey274005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof (Dr) Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Room no. 17 and 21, 265-266,APC ROAD KOLKATA-700009, West Bengal
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof (Dr) Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Room no. 17 and 21, 265-266,APC ROAD KOLKATA-700009, West Bengal
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Shivangi Pandey |
| Address |
265 266 APC Road Kolkata 700009, West Bengal |
| Type of Sponsor |
Other [The study is self-sponsored] |
|
|
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 Shivangi Pandey |
The Calcutta Homoeopathic Medical College and Hospital |
Department of Practice of Medicine, Room no 17 and 21, 265-266,APC Road Kolkata-700009, West Bengal
Kolkata
WEST BENGAL |
7003253248
shivangii.pandey274005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of The Calcutta Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G933||Postviral fatigue syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
The enrolled patients will be receiving individualized homoeopathic medicine, after a detailed or thorough case-taking in accordance with the directions laid down in the Organon of Medicine. After comprehensive case taking the Totality of Symptoms (TOS) will be formed and the similimum will be chosen as per the individual symptomatology of the patient.
Selection of Potency will be made depending on the individual case. Repetition of doses and change of potency will be done according to the individualization of the case and following homoeopathic philosophy. Chalder fatigue scale will be measured at baseline and every month upto 3 months after treatment with the medicine.Along with the medicine, the enrolled patients will receive advices on general management and lifestyle modifications. Relevant investigations will be done as per need.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Fatigue lasts for at least 6 months and is not relieved by rest.
2.Fatigue resulting in substantial reduction in previous occupational, educational, social and personal activities.
3.Presence of any other symptoms related with fatigue: muscle pain, headache, unrefreshing sleep, malaise after exertion, impaired memory, deterioration in the concentration level.
4.Scoring will be done using Likert scoring system, where minimum score possible would be 3 and a maximum of 33.
5.Patients with the age group from 18 to 60.
6.Individuals who can read and/or write English/Bengali/Hindi.
7.Individuals willing to participate in trial and give written consent for the same.
|
|
| ExclusionCriteria |
| Details |
1.Individuals who are currently on any other homoeopathic treatment or undergoing any kind of treatment for chronic fatigue from any system of medicine.
2.Individuals with any life threatening disease.
3.Pregnant or lactating mothers.
4.Patient with any Systemic Disorder, Major depressive disorder (psychotic features) or bipolar disorder.
5.Patient below 18 and above 60 years of age.
6.mmunocompromised individuals.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To detect pre- and post-treatment score using CHALDER FATIGUE SCALE in patients with chronic fatigue syndrome. |
At baseline and after 3 months of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the changes in the quality of life with SF 12 scores.
2.To shortlist accessory circumstances in chronic fatigue syndrome
3.To shortlist most indicated medicines in chronic fatigue syndrome. |
At baseline & after 3 months of treatment. |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
01/12/2025 |
| 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 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
|
Chronic fatigue syndrome [ICD-11 code 8E49], is characterized by severe, persistent exhaustion that significantly limits daily activities and is not relieved by rest. This fatigue often worsens with physical or mental exertion and is accompanied by other debilitating symptoms. In addition to fatigue, individuals may experience a range of symptoms, such as post-exertional malaise, neuro-cognitive symptoms (confusion or slow thinking), muscle pain, joint pain, sleep disturbances, hypersensitivity to stimuli, flu like symptoms, autonomic dysfunction (weakness and tremors), and immune system abnormalities that are usually made worse by exertion and not better explained by a different underlying aetiology. CFS is a severe illness that can lead to significant physical impairment, leaving patients immobile and requiring extensive care. This care may include hospitalizations for acute episodes, home support for daily activities, and outpatient management involving medications, physical therapy, and mental health services. Neuro-cognitive deficits, chronic exhaustion, and flu-like symptoms are some of the disease’s hallmarks. |