| CTRI Number |
CTRI/2025/10/096133 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Homoeopathic medicine Passiflora Incarnata in cases of Insomnia |
|
Scientific Title of Study
|
Efficacy of Homoeopathic medicine Passiflora Incarnata 200C in treatment of Insomnia |
| 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 Hani Suthar |
| Designation |
M.D. Scholer |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Department of Homoeopathic Medicine, Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar Baug, Bhalej Road Anand, 388001
Anand
GUJARAT
388001
India |
| Phone |
6354326744 |
| Fax |
|
| Email |
hanisuthar3025@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bankim Patel |
| Designation |
Associated Professor of Homoeopathic Materia Medica |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute, Anand |
| Address |
Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar Baug, Bhalej Road Anand, 388001
Anand
GUJARAT
388001
India |
| Phone |
9428066383 |
| Fax |
|
| Email |
pramukh.homeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hani Suthar |
| Designation |
M.D. Scholer |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute, Anand |
| Address |
Department of Homoeopathic Medicine, Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar Baug, Bhalej Road Anand, 388001
Anand
GUJARAT
388001
India |
| Phone |
6354326744 |
| Fax |
|
| Email |
hanisuthar3025@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Hani Suthar |
| Address |
90 - B Devbhoomi Bunglows , Shamlaji Road , Modasa, Gujarat, India - 383315 |
| 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 Hani Suthar |
Anand Homoeopathic Hospital, Anand |
Department of Homoeopathic Medicine, Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar Baug, Bhalej Road Anand, 388001
Anand
GUJARAT |
06354326744
hanisuthar3025@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Passiflora Incarnata 200C as a Homoeopathic Medicine |
The intervention will consist of Passiflora Incarnata 200C in potentized form of homeopathic Medicine, orally in the dose of 4 globules thrice daily, with frequency and repetition modified according to individual response and homeopathic principles. Follow - up assessments will be conducted every 10 days using Athens Insomnia Scale ( AIS ) to monitor therapeutic response. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Acute And Chronic Insomnias.
2.Willingness to participate and provide written informed consent.
3.Patients of both sexes. |
|
| ExclusionCriteria |
| Details |
1.Patients above 60 years and below 20 years.
2.Patients with any other acute illnesses.
3.Alcoholics and caffeine addicts
4.Patients who will be taking Homeopathic treatment for any illness, other than insomnia.
5.Patients who will be participate in other clinical trials.
6.Patients who will be unable to or unwilling to comply with the study protocol, such as adhering to treatment regimen and attending follow - ups visits will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the severity of symptoms of Insomnia , by using Athens Insomnia Scale score from baseline to the end of treatment with Passiflora Incarnata 200C. |
At the baseline and at the end of each follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
26/10/2025 |
| 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="6"
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
|
This clinical trial is designed to evaluate the efficacy of Passiflora Incarnate 200C in the homeopathic management of Insomnia in adults using Athens Insomnia Scale . A national survey utilizing data from the 2017 - 2018 longitudinal study in India reported that 12.7 % of adults aged 45 and older experienced insomnia symptoms. Patients that are using allopathic medications like anti - depressants drugs, SSRI ’ s, having many side effects including long - term using physical and psychological dependency, with withdrawal symptoms, mood changes, cognitive impairment, sexual dysfunctions and rebound insomnia also. Thus, become the scope of homeopathy in the treatment of insomnia with its harmless and gentle effect. Passiflora Incarnate mother tincture is widely used homeopathic remedy in cases of insomnia, thus, I will conduct my study in Passiflora Incarnate 200C as a potentized homeopathic medicine. This study will be a single - arm clinical trial conducted at Anand Homoeopathic Hospital with a sample size of 50 patients, aged 20-60 years, diagnosed with Insomnia. Participants will receive Homeopathic potentized medicine Passiflora Incarnate 200C orally, 4 globules, with dosage repetition individualized. Follow - up will occur every 10 days, and outcome will be assessed using the AIS. The primary objective is to measure the reduction in severity of Insomnia based on Athens Insomnia Scale. Data will be analyzed using a paired t - test to compare pre and post - treatment scores. This research aims to generate supportive clinical evidence for the use of Passiflora Incarnate 200C as a safe and potentially effective in the management of Insomnia. |