| CTRI Number |
CTRI/2024/09/073644 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of oil shiroabhyanga in insomnia patient. |
|
Scientific Title of Study
|
To study the efficacy of sesame oil shiroabhyanga and intake of buffalo milk in the management of nidranash. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Sudhir Bute |
| Designation |
B.A.M.S. PG scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
OPD no. 18, Swasthavritta and yoga department, Vidarbha Ayurved Mahavidyalaya Amravati
Amravati
MAHARASHTRA
444606
India |
| Phone |
8080995115 |
| Fax |
|
| Email |
prachibute4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay K Chopkar |
| Designation |
Associate Professor |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
OPD no. 18, Swasthavritta and yoga department, Vidarbha Ayurved Mahavidyalaya Amravati
Amravati
MAHARASHTRA
444606
India |
| Phone |
9423105104 |
| Fax |
|
| Email |
skchopkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Sudhir Bute |
| Designation |
B.A.M.S. PG scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
OPD no. 18, Swasthavritta and yoga department, Vidarbha Ayurved Mahavidyalaya Amravati
Amravati
MAHARASHTRA
444606
India |
| Phone |
8080995115 |
| Fax |
|
| Email |
prachibute4@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD patients of Vidarbha Ayurved Mahavidyalaya Amravati,Maharashtra, India, 444606 |
|
|
Primary Sponsor
|
| Name |
Prachi Sudhir Bute |
| Address |
Vidarbha Ayurved Mahavidyalaya Amravati, Maharashtra, India, 444606 |
| 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 Prachi Sudhir Bute |
Vidarbha Ayurved Mahavidyalaya Amravati |
OPD no. 18, Swasthavritta and yoga department, Vidarbha Ayurved Mahavidyalaya Amravati, Maharashtra,444606
Amravati
MAHARASHTRA |
8080995115
prachibute4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S. H. V. P. M. S Vidarbha Ayurved Mahavidyalaya, Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G138||Systemic atrophy primarily affecting central nervous system in other diseases classified elsewhere. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mUrdhatailam/ Sirastailam, मूरà¥à¤§à¤¤à¥ˆà¤²à¤®à¥/ शिरसà¥à¤¤à¥ˆà¤²à¤®à¥ | (Procedure Reference: Charak sutrasthan, Procedure details: Shiroabhyanga with 15-20 mL sesame oil in the morning before bath.
Duration- 2 months)
(1) Medicine Name: Sesame oil, Reference: Sushrut sutrasthan , Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 2 Months(2) Medicine Name: Buffalo milk, Reference: Sushrut sutrasthan, Route: Oral, Dosage Form: Not Applicable, Dose: 150(ml), Frequency: od, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 30-50 years.
2. Irrespective of sex, education, religion and socio-economical status.
3. Individual willing for regular follow up.
4. Individual with classical signs and symptoms of Nidranash like Nidraalpata, Bhram, Tandra, Khanditnidra, etc.
5. Individual having disturbed sleep, mild hypertension, mild depression and generalised anxiety disorder and without any complications of other diseases. |
|
| ExclusionCriteria |
| Details |
1. Subjects with age group below 30 years and above 50 years of age of both sexes.
2. Subjects having any systematic disease.
3. Contraindicated to Shiroabhyanga.
4. Old age and old age related diseases.
5. Patient not ready to give informed consent.
6. Patient with chronic diseases.
7. Patients with alcohol addiction, drug abused, accidental cases and post operative cases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the effect of sesame oil Shiroabhyanga and intake of buffalo milk in the management of Nidranash.
2. To study the effect of sesame oil shiroabhyana in nidranash.
3. To study concept of insomnia.
4. To study the effect of intake of buffalo milk in nidranash.
5. To study the combined effect of sesame oil shiroabhyanaga and intake of buffalo milk in nidranash. |
18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the conceptual aspects of Nidranash.
2. To study the properties of sesame oil & buffalo milk. 3. To study the conceptual aspects of insomnia.
|
16 months. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="5" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prachibute4@gmail.com].
- For how long will this data be available start date provided 01-09-2024 and end date provided 01-09-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Topic:- TO STUDY THE EFFICACY OF SESAME OIL SHIROABHYANGA AND INTAKE OF BUFFALO MILK IN THE MANAGEMENT OF NIDRANASH.
Aim:- To study the effect of sesame oil Shiroabhyanga and intake of buffalo milk in the management of Nidranash.
Objective:-
Primary Objective:-
To study the effect of sesame oil Shiroabhyanga and intake of buffalo milk in the management of Nidranash.
Secondary Objectives:-
1. To study the conceptual aspects of Nidranash.
2. To study the properties of sesame oil and buffalo milk.
Methodology:- Study design
Screening of the subjects from population will be done on the basis of inclusive criteria and exclusive criteria.
Selection of the subjects will be done by using lottery method. Individuals will be given sesame oil Shiroabhyanga in the morning and 150 mL of buffalo milk after the meal before going to bed.
Follow up at D-10 and after study D-60.
Then assessment will be done by objective and subjective parameters before and after the study and subjective parameters on D-0, D-10, D-20, D-30, D-40, D-50, D-60.
Statistical analysis with appropriate test and interpretation will be done.
Study Population:-
On the basis of clinical examination and history, total individuals will be selected according to their eligibility criteria.
Individuals will be given sesame oil Shirobhyanga in the morning and 150mL of buffalo milk after the meal before going to bed.
Inclusion criteria:-
1. Age group 30-50 years.
2. Irrespective of sex, education, religion, and socio-economical status.
3. Subjects with classical signs and symptoms of Nidranash like Nidraalpata, Bhram, Tandra, Khanditnidra, etc.
4. Individual willing for regular follow up.
5. Individual having disturbed sleep with mild hypertension, mild depression and generalised anxiety disorder and without any complications of other diseases.
Exclusion criteria:-
1. Individual with age group below 30 years and above 50 years of age.
2. Subject having any systemic diseases.
3. Contraindicated for Shiroabhyanga.
4. Patient having chronic diseases.
5. Patients with alcohol addiction, drug abuser, accidental cases and post operative cases.
Withdrawal criteria:-
1. Subject who develop any unwanted symptoms during the study.
2. Subjects who are unable to give follow up. |