| CTRI Number |
CTRI/2025/12/099102 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Public Health Program for Cold Wave Affected Populations |
|
Scientific Title of Study
|
Public Health program to assess the impact of Cold Wave on individuals and addressing them with Homoeopathic intervention. |
| 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 Renu Mittal |
| Designation |
Research Officer /S4 (H) |
| Affiliation |
Central council for Research in Homoeopathy |
| Address |
Room no.304, Central council for Research in Homoeopathy ,Jawahar lal Nehru Chitiksa Avum Anusandhan Bhawan .61 Opp D Block Janakpuri, south west Delhi
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Mittal |
| Designation |
Research Officer /S4 (H) |
| Affiliation |
Central council for Research in Homoeopathy |
| Address |
Room no.304, Central council for Research in Homoeopathy ,Jawahar lal Nehru Chitiksa Avum Anusandhan Bhawan .61 Opp D Block Janakpuri, south west Delhi
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research officer /S3 |
| Affiliation |
Central council for Research in Homoeopathy |
| Address |
Room no.304, Central council for Research in Homoeopathy ,Jawahar lal Nehru Chitiksa Avum Anusandhan Bhawan .61 Opp D Block Janakpuri, south west Delhi
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in homoeopathy,Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan,61-65 ,Institutional Block Janakpuri ,New Delhi-110058 South West Delhi ,India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in homoeopathy |
| Address |
Central Council for Research in homoeopathy,Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan,61-65 ,Institutional Block Janakpuri ,New Delhi-110058 South West Delhi ,India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAmit Srivastava |
CRI(H) , LUCKNOW |
CRI(H) LUCKNOW,Sector 2,Janakipuram Extension Near Vithouli Crossing, Lucknow
Lucknow
UTTAR PRADESH |
9140577532
dramit911@gmail.com |
| Dr Uttam Singh |
CRI(H) ,JAIPUR |
CRI(H), JAIPUR, Sector 26 Pratap Nagar ,
Jaipur
RAJASTHAN |
9899144235
druttam01@gmail.com |
| Dr Shweta Gautam |
DDPRCR ( H) NOIDA |
DDPRCR (H) Noida ,A-1/1,sector 24 ,Gautam Budh Nagar,Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9999566890
drshwetagtm@gmail.com |
| Dr Santosh Tamang |
RRI (H) Gangtok |
RRI (H), Indira Bypass Road,Near SDF Bhawan .Lingding,Post Office: Tadong , Gangtok
East
SIKKIM |
8250332201
crugangtok@gmail.com |
| DrNitin Kumar Saklani |
RRI (H) Shimla |
C-5 lane 1, Sector 2, Below B.C.S New Shimla
Shimla
HIMACHAL PRADESH |
8744021902
rrishimla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X31||Exposure to excessive natural cold, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
individualised homoeopathic medicine |
The individualized homoeopathic medicines are manufactured by Good Manufacturing Practice (GMP) compliant pharmaceutical firms. Indicated homoeopathic medicines will be dispensed in centesimal potencies in sugar globules of standard size 30. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Phase 1: People who can be interviewed directly and who can respond to the questions of the survey.
All participants aged above 18 years, of all genders, living in cold wave-prone urban and rural areas
Phase 2
All participants aged above 12 years, of all genders, living in Cold wave-prone urban and rural areas.
Participants with symptoms of cold waves reported to the health camps and OPDs.
|
|
| ExclusionCriteria |
| Details |
PHASE 1
People refusing consent to participate in the survey
People who are not residing permanently in the cold wave-prone urban and rural areas.
PHASE 2
Participants suffering from uncontrolled systemic diseases (like Diabetes mellitus, Cancer, Hypertension), uncontrolled infections, or any vital organ failure.
•Pregnancy and lactation.
•Participants refusing consent for the homoeopathic treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PHASE -1
Assessment of awareness of population about cold wave conditions
•Knowledge about cold wave related illnesses assessed using the questionnaire
•Assessment of management of previously suffered cold wave illnesses
•Impact of cold wave conditions on daily living and health of individuals and family units
•Assessment of community awareness with respect to cold wave preparedness in different regions .
PHASE 2: To assess the severity of symptoms caused by cold waves using a numeric rating scale (to be assessed twice a week). |
To be assessed twice a week for 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1291"
Sample Size from India="1291"
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)
|
23/12/2025 |
| 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="0"
Months="3"
Days="15" |
|
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
|
Public Health program to assess the impact of Cold Wave on
individuals and addressing them with Homoeopathic intervention will be underatken at 5 centers with phase 1 Cross-sectional population survey in cold wave-prone urban and rural areas and Phase 2 -Individualized Homoeopathic
intervention to the participants reporting for the treatment in the Health Camp
and OPDs .The primary objective for phase 1 is to assess community
awareness, perceptions, and behavioural responses to cold wavesand to assess the impact of cold waves
in the identified regions and public preparedness in dealing with new episodes
in future and for phase 2 is to assess the impact of cold waves in the identified regions and public preparedness in dealing with new episodes in future. outcome of phase 1 is Assessment of awareness, Knowledge ,Management,Impact,with respect to cold wave
preparedness in different regions and for phase 2 is to assess the severity of symptoms caused by cold
waves using a numeric rating scale .
|