| CTRI Number |
CTRI/2023/08/056469 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to evaluate the effect of Ksheerbala Tail Abyang and Nasya in the management of Insomnia |
|
Scientific Title of Study
|
A cinical study of Ksheerbala Taila Abhyanga and Ksheerabala Taila Nasya in the management of Anidra(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 Rakesh Katara |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurved, DSRRAU, Jodhpur |
| Address |
PG Department of Panchkarma, Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Kadwad, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9928695225 |
| Fax |
|
| Email |
rakeshkatara162@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurved, DSRRAU, Jodhpur |
| Address |
PG Department of Panchkarma, Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Kadwad, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurved, DSRRAU, Jodhpur |
| Address |
PG Department of Panchkarma, Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Kadwad, Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Kadvad Jodhpur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Kadvad, Nagaur Road Jodhpur,Rajasthan 342037 |
| Type of Sponsor |
Government medical college |
|
|
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 Rakesh Katara |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, University Hospital Of Ayurved |
OPD No.7 PG Deparment of Panchkarma, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur
Jodhpur
RAJASTHAN |
9928695225
rakeshkatara162@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, JODHPUR, PGIA, INSTITUTIONAL ETHICS 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. Ayurveda Condition: NIDRA-VAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग and  Nasya | (Procedure Reference: Charak Sutra 5/85-86 and Sushrut Chikitsa 40/25, Procedure details: Abhyanga ("oil massage") is a form of Ayurvedic therapy that involves massage of the entire body from the head to the toe with Dosha-specific warm herb-infused oil in 7 position.
Nasya - Nasya will be done according to SOP.
)
(1) Medicine Name: Ksheerbala Taila, Reference: Sahastra Yog , Route: Topical, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days(2) Medicine Name: Ksheerbala Taila, Reference: Shastra Yog, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a)Diagnosed and confirmed cases of insomina, as per Case Report Form & on the basis of the sign & symptoms.
b)Individual between the age group of 18 to 70 of both sexes having insomnia.
c)Insomnia with mild hypertensions
d)Insomnia with mild depression and anxiety disorders without any complications of any other disease.
|
|
| ExclusionCriteria |
| Details |
a)Patients below 18years and above 70 years of age.
b)Major psychiatric illness like schizophrenia, depression, epilepsy etc not registered.
c)Alcohol dependency & drugs dependency excluded.
d)Chronic illness like asthma, renal failure, diabetes etc excluded.
e)Acute illness like cerebro-vascular accidents, congestive cardiac failure, myocardial infarction, chronic obstructive pulmonary disease and similar other disorders excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the effect of ksheerbala taila by abhyanga & nasya in the management of anidra (insomnia) by PITTSBURGH SLEEP QUALITY INDEX |
30 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of life. |
30 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
21/08/2023 |
| 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="1"
Months="0"
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
|
This study is single arm, an open label trial, with single group of 30 patients to assess the efficacy of ksheerbala taila by abhyanga and nasya in the management of anidra (insomnia). The primary objective of present study is reducing subjective parameter -Jrimbha (Yawning), Tandra (Drowsiness), Angamarda/Angasada (Malaise), Arati/ Klama (Fatigue & inertness) Sirahshools (Headache), Manodourbalya (Lack of concentration), Smiritidourbaliya (Loss of memory), Indriya karmahani (Poor sensory perception), Ajirna /Agnimandhya (Indigestion), Malabaddhata (Constipation), Dhatu kshaya (Weight loss), Kanti kshaya (Loss of luster) usimg PITTSBURGH SLEEP QUALITY INDEX. Abhang in 7 position and Nasya in the dosage of 6 -6 drops will be done for 14 days using Ksheerbala Taila. |