| CTRI Number |
CTRI/2025/07/090671 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MANAGEMENT OF ANIDRA THROUGH PADABHYANGA AND SARPGANDHA CHURNA |
|
Scientific Title of Study
|
A COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF PADABHYANGA AND SARPGANDHA CHURNA IN MANAGEMENT OF ANIDRA W.S.R. TO 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 Ashadeep |
| Designation |
MD SCHOLAR |
| Affiliation |
Tantia university |
| Address |
PG DEPARTMENT OF SWASTHVRITTA AND YOGA, SRIGANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL, TANTIA UNIVERSITY, SRI GANGANAGAR RAJASTHAN
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9649449849 |
| Fax |
|
| Email |
ashumahal3491@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudesh Kumar bhambu |
| Designation |
ASSOCIATE PROFESSOR DEPARTMENT OF SWASTHVRITTA AND YOGA |
| Affiliation |
Tantia university |
| Address |
DEPARTMENT OF SWASTHVRITTA AND YOGA, SRIGANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL, TANTIA UNIVERSITY, SRIGANGANAGAR
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9468709698 |
| Fax |
|
| Email |
drskb07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudesh Kumar bhambu |
| Designation |
ASSOCIATE PROFESSOR DEPARTMENT OF SWASTHVRITTA AND YOGA |
| Affiliation |
Tantia university |
| Address |
DEPARTMENT OF SWASTHVRITTA AND YOGA, SRIGANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL, TANTIA UNIVERSITY SRIGANGANAGAR
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9468709698 |
| Fax |
|
| Email |
drskb07@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG DEPARTMENT OF SWASTHAVRITTA AND YOGA, SRI GANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL, TANTIA UNIVERSITY, SRI GANGANAGAR |
|
|
Primary Sponsor
|
| Name |
SRIGANGANAGAR COLLEGE OF AYURVEDIC SCIENCE TANTIA UNIVERSITY SRI GANGANAGAR |
| Address |
TANTIA UNIVERSITY, HANUMAN GARH ROAD RICCO, SRIGANGANAGAR, RAJASTHAN 335002 |
| Type of Sponsor |
Other [Private Ayurveda college 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 Ashadeep |
Room no.9OPD of Department of Swasthvritta and Yoga |
Ayurved Hospital Sriganganagar college of Ayurvedic science and Hospital Tantia University Sriganganagar
Ganganagar
RAJASTHAN |
9649449849
ashumahal3491@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Sri ganganagar college of ayurvedic science and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F419||Anxiety disorder, unspecified. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarpgandha churna , Reference: Priya Nighantu , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ushna Jala/ Milk), Additional Information: -NO |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Individual between the age group of 20 to 60 years of either sex of insomnia for minimum one month duration.
Patient of insomnia with mild hypertension and anxiety disorders. |
|
| ExclusionCriteria |
| Details |
Patients having major psychiatric illness like schizophrenia, depressive psychosis, epilepsy.
- Chronic alcoholics
- Patients having as Asthma, malignancies, liver cirrhosis, chronic liver failure
- Patients having cardiovascular accident, congestive cardiac failure, chronic obstructive
pulmonary disorders, meningitis, acute painful conditions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms |
28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in objective assessment criteria of Anidra |
28days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2025 |
| Date of Study Completion (India) |
27/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/09/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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)
|
An interventional study will be done on Number of Patient 40 with administration of Sarpgandha churna along with Padabhyanga for twenty eight days. The patients will be assessed on basis of subjective and objective criteria of Anidra before and after trial. Follow up will be taken on every 7th day. The data will be collected and analyzed statistically using appropriate test. |