| CTRI Number |
CTRI/2025/10/096610 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To See How Shankhpushpi Ghee And Cow Ghee Foot Massage Help Improve Sleep Quality |
|
Scientific Title of Study
|
A Randomised Clinical Trial To Evalaute The Role Of Shankhapushpi Ghrita And Go Ghrita Padabhayanga In Improving The Quality Of Nidra |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSargam Baghel |
| Designation |
PG Scholar |
| 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 |
7828459011 |
| Fax |
|
| Email |
sargambaghel1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDhananjay patil |
| Designation |
Associate professor |
| 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 |
9970044572 |
| Fax |
|
| Email |
patil.dhananjay@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrDhananjay patil |
| Designation |
Associate professor |
| 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 |
9970044572 |
| Fax |
|
| Email |
patil.dhananjay@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) |
|
|
Primary Sponsor
|
| Name |
Dr Sargam Baghel |
| Address |
Bharati Vidyapeeth (Deemed to be University)
College Of Ayurved and
hospital
bharati educational campus
department of swasthavritta opd no. 15
Ground floor
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 |
| Dr Sargam Baghel |
Bharati Vidyapeeth (Deemed to be University) |
College of Ayurved, Department of Swasthavritta evum Yoga, OPD no 15, Katraj - Dhankawadi, Pune 411043
Pune
MAHARASHTRA |
7828459011
sargambaghel1998@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-411 043. INSTITUTIONAL ETHICS COMMITTEE BV(DU)COA-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Improving Quality of Sleep |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: (कैय्र्देव ननघण्टु), Procedure details: Pradhana Karma (Main Procedure – Padabhyanga Technique):
• An appropriate quantity of 10–20 ml of lukewarm Shankhapushpi ghrita is taken in the palm and
applied over both soles of the feet.
The ghrita is spread evenly over the soles, heels, toes, and ankles.
• The following sequence of strokes is followed for each foot:
1. Gentle circular strokes on the soles using the thumb.
2. Long strokes from heel to toes using the palm.
3. Circular movement around the ankle joints.
4. Kneading of the heel and ball of the foot.
Padabhyanga is performed for 10-15 minutes for both foot.
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: shankhapushpi ghrita, Reference: (कैय्र्देव ननघण्टु), Route: Topical, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Acharya G S, Procedure details: Pradhana Karma (Main Procedure – Padabhyanga Technique):
• An appropriate quantity of 10–20 ml of lukewarm Shankhapushpi ghrita is taken in the palm and
applied over both soles of the feet.
The ghrita is spread evenly over the soles, heels, toes, and ankles.
• The following sequence of strokes is followed for each foot:
1. Gentle circular strokes on the soles using the thumb.
2. Long strokes from heel to toes using the palm.
3. Circular movement around the ankle joints.
4. Kneading of the heel and ball of the foot.
Padabhyanga is performed for 10-15 minutes for both foot.
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: ghrita, Reference: vagbhata, Route: Topical, Dosage Form: Ghrita, 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. Patients willing to give informed consent and follow the treatment protocol.
2. Male and female individuals of 18 to 25 age will be enrolled.
3. Individuals experiencing sleep disturbances for more than 3 weeks .
4. Individuals clinically diagnosed with Quality of nidra (primary insomnia) as per Ayurvedic criteria.
5. Pittsburgh Sleep Quality Index total score between 5 and 21 is indicative of poor sleep
quality. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Patients below 18 or above 25 years of age.
2. Individuals suffering from other metabolic disease due to systemic diseases
3. Patients with psychiatric illnesses such as depression, schizophrenia, or bipolar disorder.
4. Individuals currently taking sedatives, hypnotics, or undergoing any form of insomnia treatment
5. Individuals with neurological disorders (e.g., epilepsy, Parkinson’s disease). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Patients below 18 or above 25 years of age.
2. Individuals suffering from other metabolic disease due to systemic diseases
3. Patients with psychiatric illnesses such as depression, schizophrenia, or bipolar disorder.
4. Individuals currently taking sedatives, hypnotics, or undergoing any form of insomnia treatment
5. Individuals with neurological disorders (e.g., epilepsy, Parkinson’s disease). |
Base line, 7th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
5. Enhanced sleep efficiency.
6. Reduced daytime dysfunction.
7. Enhanced mental calmness and cognitive clarity, owing to the Medhya (nootropic) and Snigdha
(unctuous) properties of both interventions |
Base line 21th day |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
Modification(s)
|
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
|
In parallel Padabhyanga therapeutic foot massage with GoGhrita is a cornerstone of Dinacharya daily regimen known to balance Vata dosha and calm the nervous system through Marma stimulation and Snehana oleation The soles of the feet are rich in nerve endings and are connected to vital organs making them a therapeutic site for achieving systemic relaxation While the benefits of both these therapies are well-cited in classical texts and some contemporary anecdotal observations no comprehensive clinical trial has been conducted to evaluate and compare their individual and combined effects on the quality of sleep
|