| CTRI Number |
CTRI/2023/01/049059 [Registered on: 17/01/2023] Trial Registered Prospectively |
| Last Modified On: |
02/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Management of Insomnia by Ayurvedic Errhine Therapy |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Shankapushpi Taila Nasya versus ksheerbala Taila Nasya in the Management of Anidra Primary Insomnia Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annya Satish Kumar Sharma Gautam |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Medical Sciences Wardha |
| Address |
Room no 40 Department of Pachakarma Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8218406491 |
| Fax |
|
| Email |
ananyagautam68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annya Satish Kumar Sharma Gautam |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Medical Sciences Wardha |
| Address |
Room no 40 Department of Pachakarma Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8218406491 |
| Fax |
|
| Email |
ananyagautam68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Ade |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences Wardha |
| Address |
Room no 40 Department of Pachakarma Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9689365368 |
| Fax |
|
| Email |
dr.vinodade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital And Reaearch centre |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital And Research Centre |
| Address |
Room no 40 Department of Pachakarma Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Annya Gautam |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room no 40 Department of Panchakarma Salod Hirapur Wardha
Wardha
MAHARASHTRA |
8218406491
ananyagautam68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital And Research Centre Institutional Ethics Committee Salod Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F99||Mental disorder, not otherwise specified. Ayurveda Condition: NIDRANASAH/ASVAPNAH, (2) ICD-10 Condition:G||Mental Health. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ksheerabala, Reference: Bhaishajya ratnavali, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: only observing the efficacy of Khseerabala taila not Nasya procedure | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shankhapushpi, Reference: Kaidev Nighantu, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: only observing the efficacy of Shankhapushpitaila not Nasya procedure |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are willing to give written inform consent
2.Patients either gender age between 20 to 60 years
3.Patients who are fit for Nasyakarma
4.Patient with controlled hypertension
5.ICD10 criteria for primary insomnia F51 point 01 |
|
| ExclusionCriteria |
| Details |
1.Patients less than 20 years and more than 60 years
2.Pregnant women and lactating mothers
3.Patient with co morbidities Example uncontrolled Hypertension DM2 Thyroids and Cardiac disorders
4.Patient not fit for Nasya karma Pratishyaya Trushna Ajirna Rajaswala etc
5.Patient with drug dependency like Anti histamines Narcotics
6.Occupational disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Shankhapushpi Taila and Ksheerabala Taila in Pitssburg Sleep Quality Index Insomnia severity index and Quality of life |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Shankhapushpi Taila and Ksheerabala Taila in Pitssburg Sleep Quality Index Insomnia severity index and Quality of life |
0 day 15th day 30th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
31/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/01/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the volunteer will be inform about the study protocol willing participants will be randomly selected as per computer generated table. clinical research format will be prepared and validated prior to the study approval will be taken from IEC,MGACHRC, Salod (hirapur), wardha and CTRI registration will be done. After selection, each participants will be tested individually and selected according to selection criteria. they are divided into two groups the trial is parallel group, randomized, single blind clinical, standard controlled trial. it will include 15 days treatment period and 16th and 30th day follow up period. |