| CTRI Number |
CTRI/2025/02/080687 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment in post dengue joint and muscle pain |
|
Scientific Title of Study
|
Efficacy of homoeopathic medicines in arthralgia and myalgia resulting from dengue fever- a prospective single arm interventional clinical 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 Rupali Verma |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Materia Medica
State National Homoeopathic medical College and Hospital, Viraj Khand 1 Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8240368120 |
| Fax |
|
| Email |
sarushi.verma975@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Dileep Kumar Sonkar |
| Designation |
Head of Department |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Physiology
State National Homoeopathic medical College and Hospital, Viraj Khand 1 Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
07398204457 |
| Fax |
|
| Email |
drdksonkar86992@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Verma |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic medical College and Hospital Lucknow |
| Address |
Department of Materia Medica
State National Homoeopathic medical College and Hospital Viraj Khand 1 Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8240368120 |
| Fax |
|
| Email |
sarushi.verma975@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College Viraj Khand 1 Gomti nagar Lucknow Uttar Pradesh India 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Rupali Verma |
| Address |
Department of Materia Medica
State National Homoeopathic Medical College Viraj Khand 1 Gomti Nagar Lucknow |
| Type of Sponsor |
Other [Sellf] |
|
|
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 Rupali Verma |
State National Homoeopathic Medical College Lucknow |
Department of Materia Medica
State National Homoeopathic medical College and Hospital, Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH |
82403 68120
sarushi.verma975@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State National Homoeopathic Medical College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicines with lifestyle modification |
Intervention planned as after obtaining consent and proper case taking of all enrolled patients will be done in a standardized case taking proforma which is being used in state national homeopathic Medical College and Hospital.
individualised homeopathic medicine will be prescribed to all patients after analysis and evaluation of symptoms and proper report indicated homeopathic medicine will be administered to the case or condition in required potency in centesimal scale depending upon the susceptibility of the patients.
Each dose shall consist of 4-5 globules made of cane sugar medicated with single medicine (preserved in 90% v/v ethanol)
To be taken orally on empty stomach.
each case will be followed up at regular interval as per requirement preferably at a period of 15 days.
each patient will be studied for 1 year after enrollment in study general management which includes appropriate diet regimen and proper lifestyle modification will be advised as when required progress of patient will be assessed through Dengue Severity Score |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient of age between 18 years to 65 years
2) patient who suffered from dengue fever in past 12 months
3) diagnostic criteria is based on clinical presentation and blood test finding
4)patient who are suffering from myalgia and arthralgia with history of dengue fever in the past
5) patient giving consent to participate |
|
| ExclusionCriteria |
| Details |
1) Patient of age below 18 years.
2) Patient suffering from-
a) Acute fatty liver disease
b) Chronic liver disease (hepatitis B, hepatitis C, Primary biliary cirrhosis, primary sclerosing cholangitis, symptomatic cholelithiasis, cholecystitis)
c) Smoking/alcohol/drug addiction
d) Dermatological diseases with itching
e) Allergic/Drug reaction,
f)Haemoglobinopathy/coagulation disorders.
3) Any other condition requiring emergency or surgical Intervention,
4) Patient unwilling for Inclusion in the study and those who are not able to come for follow up
5) Lactating and pregnant mother
6) Patients suffering from diseases such as osteoarthritis, rheumatoid arthritis, gout and other calcium deficient conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of study, it is expected that homoeopathic medicines given have effective role in the management of patients who are suffering from arthralgia and myalgia resulting from dengue fever |
4 weeks 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
If the results will be positive, a certain group of remedies can be observed which are frequently indicated in the cases of arthralgia and myalgia resulting from dengue fever.
The study will determine if the quality of life can be improved by using homeopathic medicines in cases of arthralgia and myalgia resulting from dengue fever.
Lastly the study will go into public domain and will be beneficial for public. |
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)
|
28/02/2025 |
| 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="0"
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 study is to assess the efficacy of homoeopathic medicine in post dengue bone and muscle pain. In recent cases of dengue fever it is observed that many of the patients are suffering from post dengue muscle and bone pain which was not prevalent before. Need of the study is to reduce the burden of this complications through proper homoeopathic medicinal management which includes the patients suffered from post dengue arthralgia and myalgia. Cases are to be followed on regular basis in every 15 days, and results are to be assessed on the basis of clinical symptoms, changes in the dengue infection severity score. |