| CTRI Number |
CTRI/2025/01/078973 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Head massage with Ayurvedic medication as local application. |
|
Scientific Title of Study
|
Study the Efficacy of Ashwagandha Siddha Taila Shiroabhyanga on Mentally Stressed Individuals. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manali Sandeep Zarkar |
| Designation |
Pg Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Department of Swasthavritta and Yoga, OPD no 15, Bharati Vidyapeeth (Deemed to be University), College of Ayurved, dhankawadi, Pune 43 Satara Road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8237448233 |
| Fax |
|
| Email |
manali.zarkar-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudeep Menon |
| Designation |
Associate professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be university) |
| Address |
Department of Swasthavritta and Yoga, OPD no 15,Bharati Vidyapeeth (Deemed to be University), College of Ayurved, dhankawadi, Pune 43 Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8007283293 |
| Fax |
|
| Email |
sudeep.menon@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudeep Menon |
| Designation |
Associate professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be university) |
| Address |
Department of Swasthavritta and Yoga, OPD no 15,Bharati Vidyapeeth (Deemed to be University), College of Ayurved, dhankawadi, Pune 43 Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8007283293 |
| Fax |
|
| Email |
sudeep.menon@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be) university College of Ayurved and Hospital, Pune Satara road, Pune 43 |
|
|
Primary Sponsor
|
| Name |
Dr Manali Sandeep Zarkar |
| Address |
Swasthavritta Evum Yoga OPD, ground floor room number 15, Bharati Vidyapeeth (Deemed to be) university College of Ayurved and Hospital, Pune Satara road, Pune-43 |
| 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 Manali Sandeep Zarkar |
College of Ayurved and Hospital |
Bharati Vidyapeeth (Deemed to be University), Department of Swasthvritta and Yoga, OPD No.15,Ground floor, Katraj - Dhanakwadi Pune - 411043
Pune
MAHARASHTRA |
8237448233
manali.zarkar-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE [BV (DU) COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F489||Nonpsychotic mental disorder, unspecified. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Siddha Taila, Reference: bhavprakash, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Manas prakruti Assessment.
2. Pittsburgh Sleep Quality Index total score between 5 and 21 is indicative of poor sleep quality
3. Perceived Stress Scale Score 0-26 mild to moderate stress
4. ISMA Stress Questionnaire Score 0-13 mild to moderate stress
5. Those willing to perform Shiroabhyanga for 21 days will be recruited for trial.
|
|
| ExclusionCriteria |
| Details |
1) Individuals contra-indicated for Shiroabhyanga such as Ajeerna, Nava Jwara.
2) Known case of Individuals on anti-depressants, anxiolytic medications or sedatives, etc. i.e., those suffering from severe Mental illness to avoid bias.
3) Known case of head trauma.
4) Known case of any systemic or metabolic disorders.
5) Individuals undergoing detox treatment for addiction
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lower levels of ISMA score, PSQI score, lower perceived stress scale
|
Baseline, 7th, 14th & 21st day. and Post up
follow up on 30th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
overall improved sleep quality.
|
Baseline & 30th day. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
14/02/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Ashwagandha siddha taila on mentally stressed individuals will be done on 32 individuals . This study aims at observing the effect of ashwagandha Siddha Taila in mentally stressed individuals. These people tend to have immense amount of Mental pressure on them. This Mental stress is seen as a result of many factors such as sexual, financial, environmental, etc. This study will be carried out in order to study the effect of single drug ashwagandha in the form of Taila, used as a Shiroabhyanga as a Upakrama. |