| CTRI Number |
CTRI/2025/03/083345 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ashwagandha Churna with Ghrita and Sharkara in the management of Nidrahrasa |
|
Scientific Title of Study
|
Conceptual and applied study of Nidra and effect of Ashwagandha (Withania somnifera (linn.)Dunal) Churna with Sarpi and Sharkara in Nidrahrasa |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krupal D Gamit |
| Designation |
M.D. Scholar |
| Affiliation |
Government Ayurved College and Hospital Vadodara |
| Address |
OPD No. 22 Department of Samhita Siddhanta and Sanskrit Government Ayurved College, Dhanvantari marg, Ajwa road,Panigate.
Vadodara
Vadodara
GUJARAT
390019
India |
| Phone |
08758415417 |
| Fax |
|
| Email |
drkrupalgamit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdeli Bhadarva |
| Designation |
Assisstant Professor |
| Affiliation |
Government Ayurved College and Hospital Vadodara |
| Address |
O.P.D. No.22 Department of Samhita Siddhanta and Sanskrit Government Ayurved Hospital, Ajwa road, Dhanvantari marg,Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9974059434 |
| Fax |
|
| Email |
abdelibhadarva@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Mahesh Chand Gupta |
| Designation |
Professor & Head of Department |
| Affiliation |
Government Ayurved College and Hospital Vadodara |
| Address |
O.P.D No.22 Department of Samhita Siddhnata and Sanskrit Government Ayurved College, Dhanvantari marg, Ajwa road,Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
7976228480 |
| Fax |
|
| Email |
mcgupta.76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved Hospital, Ajwa road, Dhanvantari marg, Panigate, Vadodara
390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College and Hospital |
| Address |
Government Ayurved College, Dhanvantari marg, Ajwa road,
Vadodara
GUJARAT
390019
India |
| 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 Krupal D Gamit |
Government Ayurved Hospital, Vadodara |
PG 1 OPD No.22 and IPD Government Ayurved Hospital, Ajwa road, Dhanvantari marg,
Panigate, Vadodara 390019
Vadodara
GUJARAT |
08758415417
drkrupalgamit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurved College & Hospital, Vadodara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G478||Other sleep disorders. 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 Churna, Reference: Vangsen Samhita 85/13, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Sarpi and Sharkara), Additional Information: Adhobhakta (Nishi Kaala) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 60 years.
Subjects having symptoms of Nidrahrasa.
Complaining of reduction in sleep time, difficulty in initiation of sleep, lack of sleep if awakened in midnight. |
|
| ExclusionCriteria |
| Details |
K/C/O of diabetes mellitus.
Pregnant women and lactating mothers.
Subjects suffering from any kind of pain due to
known illness.
Subject having drug induced insomnia.
Severe psychiatric subjects on treatment. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the efficacy of Ashwagandha churna with Sarpi and Sharkara in Nidrahrasa |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduced anxiety
Improved cognitive functioning |
21 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 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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 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
|
An open labelled single arm clinical trial will be conducted involving 30 patients diagnosed with Nidrahrasa. Participants will undergo for treatment of 21 days and follow up for 1 month once a week. The primary outcome measures included symptomatic relief. |