| CTRI Number |
CTRI/2022/07/044456 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of Nasya karma with Jyothishmati Taila and Oral administration of Ashwagandha Root Extract in the managementof Sleep Onset Insomnia(Nidra Nasha) |
|
Scientific Title of Study
|
Clinical Evaluation Of Jyotishmati Taila Nasya And Ashwagandha Root Extract In Sleep Onset Insomnia W.S.R. To Nidra Nasha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V BHARATHI |
| Designation |
MEDICAL OFFICER |
| Affiliation |
Dr N.R.S. Govt Ayurvedic College |
| Address |
Dr N.R.S. Govt Ayurvedic College Dept of Kayachikitsa MG Road Vijayawada 520010
Dept of Kayachikitsa Dr N R S Govt Ayurvedic College MG Road Vijayawada 520010
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
09440486521 |
| Fax |
|
| Email |
bharathivtkr430@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K LAVANYA LAKSHMI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Dr N.R.S. Govt Ayurvedic College |
| Address |
Dr N.R.S.GOVT AYURVEDIC COLLEGE
DEPT. OF KAYACHIKITSA
MG ROAD, VIJAYAWADA
Dr N R S Govt Ayurvedic College
Dept OF KAYACHIKITSA
MG Road Vijayawada
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
8106567271 |
| Fax |
|
| Email |
kjlldr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V BHARATHI |
| Designation |
MEDICAL OFFICER |
| Affiliation |
Dr N.R.S. Govt Ayurvedic College |
| Address |
DR N.R.S.GOVT.AYURVEDIC COLLEGE
DEPT. OF KAYACHIKITSA
MG ROAD VIJAYAWADA
Dr N R S Govt Ayurvedic College
Dept of Kayachikitsa
MG Road Vijayawada 520010
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
09440486521 |
| Fax |
|
| Email |
bharathivtkr430@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. N.R.S.GOVT.AYURVEDIC COLLEGE
MG ROAD, VIJAYAWADA 520002 |
|
|
Primary Sponsor
|
| Name |
Dr V Bharathi |
| Address |
Second floor Flat no-213, Aditya Elite Apartments, Seshamsetty Road, Vaddeswaram, Guntur Dt 522302 |
| 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 V BHARATHI |
DR N.R.S. GOVT. AYURVEDIC COLLEGE |
MG ROAD,Vijayawada
Krishna
ANDHRA PRADESH |
09440486521
bharathivtkr430@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: SUSRUTA SAMHITA CHIKITSA STHANA 40/21, Procedure details: Nasya with Jyotishmathi Taila 3-4 drops in both nostrils 1hour before bed time daily and will be administered for 15 days)
(1) Medicine Name: ashwagandha root extract, Reference: INTERNET SOURCE, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: od, Duration: 40 Days | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: tagara, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 20-60 years, irrespective of gender, with symptoms like disturbed sleep, fatigue, heaviness of head, heaviness of body and frequent yawning, with no hormonal imbalances |
|
| ExclusionCriteria |
| Details |
Patients age less than 20 years, more than 60 years, with chronic illnesses, drug addicts, alcoholics, psychiatric patients, pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Signs and Symptoms and significant improvement of subjective parameters, teststo 50% baseline |
Treatment period of 40 days with follow up at 15-40-60-90 days with active follow up of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in Signs and Symptoms and significant improvement of Objective parameters |
Treatment period of 40 days with follow up at 15-40-60-90 days with active follow up of 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
07/08/2022 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A clinical trial will be done to evaluate the efficacy of Jyotishmati taila nasya and ashwagandha root extract orally in the management of Insomnia vis-a-vis Nidra Nasha and to validate scientifically the observations that would significantly change the signs and symptoms of Insomnia. Nasya is a unique procedure for urdhwa jatrugata rogas which is mentioned in several ayurvedic texts like Charaka Samhita and Susruta Samhita and will be performed on 50 patients with Jyotishmati Tailam which has a reference from Bhavaprakasa along with Ashwagandha root extract 500 mg oral administration for 40 days. The study would be conducted in India aimed to complete in 3 years and the trial time being 21 months. Primary out-come measures will be relief in signs and symptoms(Subjective Parameters) |