| CTRI Number |
CTRI/2025/02/080382 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy in Depression, Anxiety & Stress in NCD patients |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicines in management of Depression, Anxiety & Stress in patients with non- communicable diseases A Multicentric randomized placebo- controlled trial |
| 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 Bharti Wadhwa |
| Designation |
Research Officer (H)/Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No. 417,Central Council for Research in Homoeopathy,D Block,Janakpuri Institutional Area,Janakpuri, New Delhi
South West
DELHI
110058
India |
| Phone |
09818262049 |
| Fax |
|
| Email |
bhartiwadhwa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Research Officer (H)/Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No. 417,Central Council for Research in Homoeopathy,D Block,Janakpuri Institutional Area,Janakpuri, New Delhi
DELHI
110058
India |
| Phone |
09818262049 |
| Fax |
|
| Email |
bhartiwadhwa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Research Officer (H)/Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No. 417,Central Council for Research in Homoeopathy,D Block,Janakpuri Institutional Area,Janakpuri, New Delhi
DELHI
110058
India |
| Phone |
09818262049 |
| Fax |
|
| Email |
bhartiwadhwa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, Janakpuri,New Delhi,India 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
D Block,Janakpuri Institutional Area,Janakpuri, New Delhi,India 110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uttam Singh |
Central Research Institute (H), Jaipur |
Room No. 6, Clinical research department, Central Research Institute (H),Sector-26,Pratap Nagar,Jaipur,Rajasthan, India 302033
Jaipur
RAJASTHAN |
9679593673
druttam01@gmail.com |
| Dr Pankhuri Mishra |
Dr. D.P. Rastogi Central Research Institute (H) |
Room No. 205, ,Clinical research Department, Dr. D.P. Rastogi Central Research Institute (H), A-1/1 Sector 24, Noida, Uttar Pradesh, India 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9968533904
drpankhuri7hc@gmail.com |
| Dr R Bhuvaneswari |
National Homoeopathy Research Institute in Mental Health |
Room No. 106, Clinical Research department, National Homoeopathy Research Institute in Mental Health Sachivothamapuram (PO)Kurichy Kottayam, Kerala,India 686532
Kottayam
KERALA |
8281475541
drbhuvaneswarir@gmail.com |
| Dr Amulya Ratna Sahoo |
Regional Research Institute (H), Guwahati |
Room No. 102,Clinical research Department,Regional Research Institute (H), Ground Floor, CARI Old Building, (Ayurvedic Campus), Barsojai (Bhetapara), P.O. Beltola Guwahati, India 781028
Kamrup
ASSAM |
8763721546
drarsahoo@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Central Ethical Committee |
Approved |
| Institutional Ethics Comittee (Noida) |
Approved |
| Institutional Ethics Committe (Jaipur) |
Approved |
| Institutional Ethics Committe (Kottayam) |
Approved |
| Institutional Ethics Committee (Guwahati) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homeopathy |
Individualized Homeopathic medicines will be given.
The dose of the medicine will be in centisimal potency in the form of globules (4 globules/dose).
Frequency of the medicine will be as per discretion of the prescribing investigator as per improvement in the case.
Route of administration will be oral in the form of globules (4pills/dose).
Total duration of intervention will be 06 months with 1st Follow up after 2 weeks of enrollment followed by monthly follow ups.
|
| Comparator Agent |
Placebo |
Identical looking placebo will be given in another group.
The dose of the medicine will be in the form of globules (4 globules/dose).
Frequency of the medicine will be twice a day.
Route of administration will be oral in the form of globules (4pills/dose).
Total duration of intervention will be 06 months with 1st Follow up after 2 weeks of enrollment followed by monthly follow ups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both genders and Age from 18 to 70 years.
Diagnosed cases of non-communicable diseases on medication.
Mild, Moderate & Severe cases on DASS-21 Scale.
Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from any other known psychiatric and neurocognitive disorders (except depression, anxiety and stress).
Patient under “extremely severe” category on DASS-21 score.
Patients with uncontrolled NCDs even after medication.
Patients suffering from communicable diseases like HIV,TB, Hepatitis, Leprosy etc.
Patients suffering from complications of NCDs like Diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, Heart attack, Stroke, Acute limb ischaemia, acute respiratory distress syndrome, rheumatic heart disease, deep vein thrombosis, cor pulmonale, status asthmaticus, spontaneous pneumothorax, severe anaemia/neutropenia/sepsis/metastasis in cancer or any other Systemic diseases.
Pregnant and Lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of individualized homoeopathic medicines in the management of Depression, Anxiety & Stress in patients with non-communicable diseases using DASS21 score post intervention |
Primary Outcome will be assessed at Baseline, after 2 weeks of Baseline and then every month for 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the changes in Quality of Life of patients using WHOQOL Bref Scale.
2.To assess the changes in Depression, Anxiety & Stress along with changes in respective NCDs using validated scales & measures.
|
WHO QOL Bref Scale & Investigations will be assessed at Baseline, 3 months & 6 months.
Disease specific scales will be assessed at Baseline, after 2 weeks, then every month for 6 months.
|
|
|
Target Sample Size
|
Total Sample Size="786"
Sample Size from India="786"
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 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="2"
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
|
A multicentric randomized placebo- controlled trial will be conducted to evaluate the effectiveness of individualized homoeopathic medicines in the management of Depression, Anxiety & Stress in patients with Non-Communicable diseases(NCDs). Diagnosed cases of NCDs on medication with Mild, Moderate & Severe score on DASS-21 Scale will be included. Change in the DASS-21 scale post intervention will be assessed. Secondary Objectives will be to assess Change in WHO QoL Bref Scale and Change in Depression, Anxiety & Stress and respective NCDs post intervention using validated scales and measures for each NCD.
In this Single Blind Randomized Controlled Trial, it is expected that individualized Homoeopathic medicines shall be effective in managing Depression, Anxiety and Stress in patients with Non-Communicable Diseases as compared to placebo.
|