| CTRI Number |
CTRI/2023/10/058249 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ashwagandha ksheerapaka in Anidra (Primary Insomnia) |
|
Scientific Title of Study
|
A controlled clinical study to evaluate the effect of Ashwagandha ksheerapaka in the management of Anidra w.s.r. to Primary 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 Rushikesh Dilip Chalak |
| Designation |
PG Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
SDM Trusts
Ayurvedic Medical College
Danigond Post Graduation Centre
Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Karnataka
India
Bagalkot
KARNATAKA
587315
India |
| Phone |
8888276690 |
| Fax |
|
| Email |
rushikeshchalak145@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadev S Badiger |
| Designation |
Professor and HOD |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
SDM Trusts
Ayurvedic Medical College
Danigond Post Graduation Centre
Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Karnataka
India
Bagalkot
KARNATAKA
587315
India |
| Phone |
9036701207 |
| Fax |
|
| Email |
drmsb123@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rushikesh Dilip Chalak |
| Designation |
PG Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
SDM Trusts
Ayurvedic Medical College
Danigond Post Graduation Centre
Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Karnataka
India
Bagalkot
KARNATAKA
587315
India |
| Phone |
8888276690 |
| Fax |
|
| Email |
rushikeshchalak145@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College And Post Graduation Centre |
|
|
Primary Sponsor
|
| Name |
Dr Rushikesh Dilip Chalak |
| Address |
SDM Trusts
Ayurvedic Medical College
Danigond Post Graduation Centre
Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Karnataka |
| 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 Rushikesh Dilip Chalak |
Padma Ayurvedic Hospital And Research Centre |
OPD Department Of Kayachikitsa
Ground floor
Padma Ayurvedic Hospital And Research Centre
Terdal 587315
Bagalkot
KARNATAKA |
8888276690
rushikeshchalak145@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTs Ayurvedic Medical College and Padma Ayurvedic Hospital INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
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: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha, Reference: Vangasen Smahita Jaladoshadhi yogadhikara, bhavpraksh Nighantu Guduchyadi Varga, Route: Oral, Dosage Form: Ksheerpaka, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatipatri , Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Ksheerpaka, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with classical sign & symptoms of Anidra
2.Patient who are fulfilling the American Psychiatric Association (DSM-IV) diagnostic
criteria of Primary Insomnia.
3.Patient with On-going medication of other systemic disorders which does not interfere
with the current course of insomnia will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Patient with Secondary Insomnia.
2.Patient with Alcohol dependency.
3.Patient suffering with major psychiatric disorders and other Systemic disorders.
4.Patient on Hypnotic medications, sedative drugs or any other drugs which causes
drowsiness.
5.Patient with Lactose intolerance.
6.Pregnant and lactating women will be excluded.
7.Patient denying consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of trail drug over anidra (primary insomnia) is assessed by the Pittsburgh Sleep Quality index and Patients mental status |
15day, 30 day, 45 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of trial drug & adverse drug reaction, aggravation of the symptoms of the symptoms of Anidra (Primary Insomnia). |
15day 30day 45day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
10/10/2023 |
| 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 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 - NO
|
|
Brief Summary
|
- Insomnia
is a sleep disorder that regularly effects millions of people world wide.
It leads to day time sleep, lethargy and general felling
of being unwell. It affects both physical and mental status.
Insomnia is difficulty to initiate and maintain sleep or waking to early.
- In
Ayurveda it named as Anidra/Nidranasha under different disorder and
condition.
- Objectives
of study are to evaluate the effect of Ashwagandha Ksheerpaka and
compare it to the Jatipatri Ksheerpaka effect in the
management of Anidra.
- This
is a randomized comparative clinical study. Total 40 patients of Anidra will
be selected and randomly divided into two groups A and B. Group A will be
given Ashwagandha Ksheerpaka and Group B given Jatipatri
Ksheerapaka.
- The
Pittsburgh Sleep Quality Index (PSQI) and Ayurvedic adopted scale selected
for assessment criteria. Total Study duration will be 45 days and contain
4 visits (0th day, 15th day,30th day,
45day), which includes administration of trial drug for 30 days and post
medication follow up on 45th day.
- After
study, data will be collected from case report form (CRF) and
statistically analyzed by using appropriate parametric and non-parametric
tests and results will be obtained. On that basis of results,
conclusion will be drawn.
|