| CTRI Number |
CTRI/2025/10/096224 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of the Effect of Shankhapushpi Oil Head Massage on Mental Stress in College Studets. |
|
Scientific Title of Study
|
Study the Efficacy of Shankhapushpi (Convolvulus pluricaulis) Siddha Taila Shiroabhyanga on Mentally Stressed College Going Students. |
| 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 Nikita Rajkumar Rikame |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University college of Ayurved Pune |
| Address |
College of Ayurved
Department of Swasthavritta Evum Yoga
OPD no. 15
katraj Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9922724408 |
| Fax |
|
| Email |
nikitarajkumarrikame1702@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudeep Menon |
| Designation |
Professor and HOD |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved Pune Department of Swasthavritta Evum Yoga OPD no. 15 katraj Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8007283293 |
| Fax |
|
| Email |
sudeep.menon@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudeep Menon |
| Designation |
Professor and HOD |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved Pune Department of Swasthavritta Evum Yoga OPD no. 15 katraj Dhankawadi 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
Bharati Education Campus
Pune Satara Road
Katraj Dhankwadi
Pune 411043
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Rikame |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved
Bharati Education Campus
Pune Satara Road
Katraj Dhankwadi
Pune 411043
Maharashtra |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrNikita Rikame |
College of Ayurved and Hospital |
Bharati Vidyapeeth (Deemed to be University)
College of Ayurved
Department of Swasthavritta Evum Yoga OPD no. 15
katraj Dhankawadi
Pune 411043
Pune
MAHARASHTRA |
9922724408
nikitarajkumarrikame1702@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY ), PUNE (INDIA) COLLEGE OF AYURVED PUNE SATARA ROAD PUNE 411043 INSTITUTIONAL ETHICS COMMITTEE [BV(DU)COA-IEC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental Stress |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Ashtanga Hridya, Procedure details: Pradhan Karma
Appropriate amount of lukewarm oil (10-15ml) is taken on the palm and smeared over portion of scalp above neck.
The Participants and their relatives, family members or friends should smear oil in backwards directions. For Participants with long hair, fingers have to be poked in between hair to endure proper oiling of scalp.
Following sequence of Shiroabhyanga should be observed by the Participants and their relative, family members or friends.
1) Massage from before backwards
2) Picking strokes
Duration: According to Sushrut Samhita (Dalhana Teeka) Chikitsa sthana, Adhyay 24 shlok 30, it takes about 900 matras of time for the oil to seep into deepest structures of the body. This time can be approximately considered as 288 seconds (5 minutes).
)
(1) Medicine Name: Shankhapuspi , Reference: Bhavprakash, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants with a Pittsburgh Sleep Quality Index total score between 5 and 21
2.Participants with a Perceived Stress Scale score ranging from 0 to 26
3.Those willing to perform Shiroabhyanga for 21 days will be recruited for trial.
|
|
| ExclusionCriteria |
| Details |
1.Participants contra-indicated for Shiroabhyanga such as Ajeerna and Nava Jwara.
2.Known case of Participants 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.Participants undergoing detox treatment for addiction.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of Nidranasha, Mental stress and Anxiety as indicated by post-intervention scores on PSQI, PSS, and HAM-A. |
basline, 7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of Nidranasha, Mental stress and Anxiety as indicated by post- |
basline and 21st 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)
|
01/12/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Shankhpushpi has been recognized in
Ayurveda as ‘Medhya Rasayana’
meaning a drug which rejuvenates, maintains and potentiates intellect and
memory. Shankhpushpi’s isolated compounds have also
demonstrated therapeutic potential in pertaining to anti-depressants CNS
depression, calmative, anti-oxidant, anti-amnesic properties & antistress
activity. Convolvulus pluricaulis possess several
neuropharmacological properties including nootropic, neuroprotective, anti- depressant,
anti-stress, anti-inflammatory, anti-oxidant, anti- convulsant, anxiolytic,
sedative, anti-Alzheimer’s, anti- Parkionson’s. |