| CTRI Number |
CTRI/2024/10/075508 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Homoeopathic treatment in Alzheimer Disease |
|
Scientific Title of Study
|
A placebo controlled trial on the effectiveness of constitutional Homoeopathic medicine in the treatment of Alzheimer Disease with aided therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Sharma |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar Homeopathic Medical College Hospital And Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Tantia University, Sri Ganganagar, Rajasthan, 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8076854762 |
| Fax |
|
| Email |
shivaniisharma560@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalu Munjal |
| Designation |
Professor |
| Affiliation |
Sri Ganganagar Homeopathic Medical College Hospital And Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Tantia University, Sri Ganganagar, Rajasthan, 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9660019001 |
| Fax |
|
| Email |
drshalumunjal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalu Munjal |
| Designation |
Professor |
| Affiliation |
Sri Ganganagar Homeopathic Medical College Hospital And Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Tantia University, Sri Ganganagar, Rajasthan, 335002
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9660019001 |
| Fax |
|
| Email |
drshalumunjal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Tantia University, Sri Ganganagar, Rajasthan, India, 335002 |
|
|
Primary Sponsor
|
| Name |
Shivani Sharma |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Tantia University, Sri Ganganagar, Rajasthan, India, 335002 |
| 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 |
| Shivani Sharma |
Sri Ganganagar Homeopathic Medical College Hospital And Research Institute |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute, Tantia University, Sri Ganganagar, Rajasthan, India, 335002
Ganganagar
RAJASTHAN |
8076854762
shivaniisharma560@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G300||Alzheimers disease with early onset, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homeopathic medicine |
Intervention is planned as administering indicated homeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases and the duration will be till 1 year. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All medicines will be procured from a Good Manufacturing Practice (GMP) -certified firm. |
| Comparator Agent |
Placebo |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases and the duration will be till 1 year. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of Alzheimer’s Disease with aided therapy.
2. Follow up of atleast 3 months will be considered in the study.
3. Who agreed to give consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with systemic disorder.
2. Subjects with other psychiatric disorders. (namely panic disorder, Agoraphobia, specific phobia, social phobia, post-traumatic stress disorder and obsessive compulsive disorder)
3. Any case of accident, poison, or drug reaction.
4. Patient unable to empty with regular follow ups. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ADAS-COG Score will be used to assess the sample. |
follow up after every 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the more efficacious homeopathic medicine |
1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
18/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study investigates the potential effectiveness of homoeopathy in managing Alzheimer’s disease(AD), a challenging neurodegenerative disorder with limited treatment options. Key findings suggest that homoeopathy may offer promise in alleviating cognitive decline, memory impairment, and behavioural symptoms associated with AD, while also improving overall quality of life for patients. However, the abstract acknowledges limitations in the current body of evidence, such as small sample sizes, heterogeneity of interventions, and methodological flaws in study designs. Despite these challenges, the study underscores the importance of further research to better understand the potential benefits and limitations of homoeopathy in AD management. The findings aim to contribute on the ongoing discourse surrounding integrative approaches to neurodegenerative diseases and inform future clinical practice and research endeavours in this field. |