| CTRI Number |
CTRI/2025/01/079515 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of Urtica Urens mother tincture and Individualised homoeopathic medicine in patients of Gout |
|
Scientific Title of Study
|
A randomised double arm parallel clinical study to compare the effectiveness of Urtica Urens mother tincture versus Individualised homoeopathic medicine in the management of Gout |
| 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 Nandini Maurya |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony
South
DELHI
110024
India |
| Phone |
8377954533 |
| Fax |
|
| Email |
drnandinimaurya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annapurna Sarangi |
| Designation |
Professor |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony
South
DELHI
110024
India |
| Phone |
7982775800 |
| Fax |
|
| Email |
drannapurna.sarangi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annapurna Sarangi |
| Designation |
Professor |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony
DELHI
110024
India |
| Phone |
7982775800 |
| Fax |
|
| Email |
drannapurna.sarangi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patient Department of Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Dr Nandini Maurya |
| Address |
Department of Materia Medica, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi-110024 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nandini Maurya |
Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi-110024 |
OPD No. 13 of Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi-110024
South
DELHI |
8377954533
drnandinimaurya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of Nehru Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M109||Gout, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualised homoeopathic treatment |
Individualised homoeopathic treatment intervention to be conducted on patients suffering from Gout to group B out of the two group. A complete detailed case taking according to the given case proforma and repertorization will be done according to the
homoeopathic principles and then the allocated individualised homoeopathic medicine will be given. Dose and repetition will be based upon the susceptibility of patient. Medicine will be given orally. The patient will be followed up after 15 days. |
| Intervention |
Urtica Urens mother tincture |
Patients will be randomly divided into two groups as per the computer generated randomisation chart; Group A is Urtica Urens mother tincture and Group B is Individualised Homoeopathic medicine. Urtica Urens mother tincture intervention to be conducted on patients suffering from Gout to group A out of the two groups. Medicine will be given orally. The patient will be followed up after 15 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having sign and symptoms of Gout.
2. Pre diagnosed cases of Gout.
3. Patients who have not taken any treatment for gout in the last 2 weeks.
4. Patients with serum uric acid level over 7.0 mg/dl
5. Patients giving informed consent.
6. Patients willing to come for regular followups. |
|
| ExclusionCriteria |
| Details |
1. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled
systemic illness or life- threatening infections affecting quality of life or any vital organ
failure.
2. Pregnancy, puerperium and lactation.
3. Substance abuse and/or dependence.
4. Self-reported immune-compromised state.
5. Patients who are already enrolled in some other study.
6. Patients who are not willing to give the consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gout Impact Scale |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain Visual Analogue Scale |
1 month |
| Serum Uric Acid Level |
4 weeks |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/02/2025 |
| 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
|
The study will be a Prospective, Double Arm Parallel group, open label, Randomized clinical study. Patients will be randomly allocated in 1:1 ratio by using computerised Block Randomization into 2 groups: URTICA URENS MOTHER TINCTURE treatment group and INDIVIDUALISED HOMOEOPATHIC MEDICINE treatment group. Primary objective is to evaluate which is more effective i.e., URTICA URENS MOTHER TINCTURE or INDIVIDUALISED HOMOEOPATHIC MEDICINE in management of Gout and; to assess the improvement of patient in terms of frequency of attack and severity of symptoms of Gout. Duration of study is 1 year. Sample size is 60; 30 in each group. Research Analysis Assessment of clinical response/ outcome. Relief from symptoms and suffering. Assessment of improvement by using Gout Impact Scale and Pain Visual Analogue Scale. Laboratory investigations: Serum Uric Acid
|