| CTRI Number |
CTRI/2023/10/059359 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
21/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study Insomnia in menopause and the Efficacy of Tila Taila Abyanga in Menopausal Women with special reference to Insomnia
|
|
Scientific Title of Study
|
The Study of Efficacy of Tila Taila Abhyanga in Menopausal Women with special reference to 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 |
Nikita Rajesh Sonune |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya |
| Address |
OPD NO. 18 Swasthavritta and yoga department ,Vidarbha Ayurved Mahavidyalaya and hospital,Dhanvantari Nagar,Farshi stop,Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
7770030703 |
| Fax |
|
| Email |
sonunenikita23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay K Chopkar |
| Designation |
Guide and HOD Department of Swastavritta and yoga |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya |
| Address |
OPD NO.18 Swasthavritta and yoga department,Vidarbha Ayurved Mahavidyalay and hospital,Dhanvantari Nagar,Farshi Stop,Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9423105104 |
| Fax |
|
| Email |
skchopkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Rajesh Sonune |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya |
| Address |
OPD NO.18 Swastavritta and yoga department,Vidarbha Ayurved Mahavidyalay and hospital,Dhanvantari Nagar,Farshi Stop,Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
7770030703 |
| Fax |
|
| Email |
sonunenikita23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbh Ayurved Mahavidyalaya,Amravati |
|
|
Primary Sponsor
|
| Name |
Vidarbh Ayurved MahavidyalayAmravati |
| Address |
Vidarbh Ayurved Mahavidyalay,Dhanvantari Nagar,Farshi stop,Amravati |
| 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 |
| Nikita Rajesh Sonune |
Vidarbh Ayurved Mahavidyalay,Amravati |
OPD no.18
Department of Swasthavritta and Yoga,Vidarbh Ayurved Mahavidyalay Hospital,Dhanvantari Nagar,Amravati
Amravati
MAHARASHTRA |
7770030703
sonunenikita23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vidarbha Ayurved Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: sushrut chikitsasthan, Procedure details: Purva karma:
Abhyanga yogya menopausal woman will be selected.100 ml til oil will be taken in a bowl. oil will very slightly make warm.
Pradhan karma :
The person will be given supine position. The part that has to abhyanga will keep uncovered remaining part cover by clean cloth. To start Abhyanga first of all,4 to 5 drops of tila taila will apply on scalp.4 to 5 drops oil will put in both the nostrils, ears and apply to palms and to the feet. Then abhyanga will be done to lower)
| | 2 | Comparator Arm | Procedure | - | Not applicable | (Procedure Reference: not applicable, Procedure details: Observation only)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
The Menopausal women having age between 40 to 60 years.
Married,Unmarried,widows patients.
Sleep disturbances have occured at least 3 times per week. |
|
| ExclusionCriteria |
| Details |
Age below 40 years and above 60 years.
Insomnia due to other conditions like Madatyay,Abhighat and oyher systemic diseases were excluded.
The patient underwent a hysterectomy.
Menopausal women who are ayogya for abhyang. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete remission from Nidranash 75%-100% relief
Marked improvement from Nidranash 50%-75% relief
Moderate improvement from Nidranash 25%-50% relief
Mild improvement from Nidranash _25% relief
Unchanged 0% relief |
0th day
7th day
14th day
21st day
28th day
35th day
45th day
60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission from Angamardana(Bodyache)
Remission from Tandra(Drowsiness)
Remission from Shirogorove with Shirshool(headache with heaviness in head) |
35th day
45th day
60th day |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
06/11/2023 |
| 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="10"
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
|
The Study of Efficacy of Tila Taila Abhyanga in Menopausal Women with special reference to Nidranash.Trial will be conducted in our Institute. Total 240 Menopausal Women with inclusive criteria having sign and symptoms of Nidranash will be selected and will be divided in two groups.One group will be advised Tila Taila Abhayga and other group will be observed only and result wil be compared.Primary outcome will be about evaluation of Menopausal Women with Nidranash and the secodary outcome will be about assement criteria of effect of Tila Taila Abhanga and result will be noted. |