| CTRI Number |
CTRI/2025/03/083345 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2026 |
| 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)= "0"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
02/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The present open labelled single arm clinical trial was conducted involving 30 patients diagnosed with Nidrahrasa. In cardinal symptoms highly significant improvement was observed in Shirogaurav(64%), in Jrumbha (37%) and in Angamarda( 57%). Sleep quality scale (Q- 1 to Q-28) also shows highly significant improvement. In associated symptoms of WHO Scoring pattern in Nidra Labho Yathakalam (73%), in Sukhena-Cha-Pratibodhanam (73%), in Mano-Buddhi Indriya Avyapti (76%) highly significant improvement was observed and only in Vaikarikanam-Cha Swapnanam Adarshanam (3%) non significant improvement was observed. Based on the clinical outcomes of the present study, null hypothesis is rejected and alternative hypothesis is accepted that shows there is an effect of Ashwagandha Churna with Sarpi and Sharkara in Nidrahrasa. |