| CTRI Number |
CTRI/2026/01/101847 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ashwagandha Leha taken internally and Nirgundi oil foot massage help in improving sleep problems, especially in people suffering from primary insomnia. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF ASHWAGANDHA LEHA AND NIRGUNDI TAILA PADABHYANGA IN NIDRANASH WITH SPECIAL REFERENCE TO PRIMARY 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 Yogeshwar Sakharam Bhapkar |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK |
| Address |
DEPARTMENT OF KAYACHIKITSA
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK
Nashik
MAHARASHTRA
422402
India |
| Phone |
09764264445 |
| Fax |
|
| Email |
yogeshwars.bhapkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiraman Warungase |
| Designation |
HOD & Proffesor |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK |
| Address |
DEPARTMENT OF KAYACHIKITSA
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK
Nashik
MAHARASHTRA
422402
India |
| Phone |
9420364157 |
| Fax |
|
| Email |
hiramanwarungase@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogeshwar Sakharam Bhapkar |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK |
| Address |
DEPARTMENT OF KAYACHIKITSA
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK
Nashik
MAHARASHTRA
422402
India |
| Phone |
09764264445 |
| Fax |
|
| Email |
yogeshwars.bhapkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Yogeshwar Sakharam Bhapkar |
| Address |
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON |
| 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 Yogeshwar Bhapkar |
SMBT AYURVED COLLEGE AND HOSPITAL |
OPD NO 20
DEPARTMENT OF KAYACHIKITSA
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON IGATPURI NASHIK
Nashik
MAHARASHTRA |
9764264445
yogeshwars.bhapkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT AYURVED COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. 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 leha, Reference: Vangasen Samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 15(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: - | | 2 | Comparator Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Sushrut Samhita, Procedure details: POORVAKARMA: Wash the feet with lukewarm water & gently wipe them with a clean cloth Instruct the patient to lie down in a supine position. PRADHANA KARMA: Take an adequate amount of Nirgundi Taila (at a comfortable warmth) & apply it to the feet. Massage each foot for 15 minutes. The massage will be performed in the following steps: Linear strokes on the feet. Linear strokes on the sides of the feet. Linear strokes on the dorsum of the feet. Thumb pressure on the soles & the area below the thumbs. Linear strokes on the soles. Circular movements on the pads of the feet To-and-fro motion on the soles Linear & circular massage on the toes. Linear strokes on the webbing between the toes PASCHAT KARMA: Wipe off the oil from the feet with a clean cloth.Wash the feet with lukewarm water.))
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with score in range between 8 -21 on ISI Scale.
2. Individuals of either sex, between the age group of 18 to 60 years, regardless of their socio-economic background.
3. Patients presenting with complaints of insomnia, including difficulty in falling asleep, frequent awakenings, early morning awakening, or difficulty maintaining sleep, occurring more than
three times a week for at least one month, despite having adequate opportunity for sleep.
4. Presence of associated daytime impairments such as drowsiness, heaviness of the body, fatigue, irritability, reduced memory, and poor concentration.
5. Patients complaining of Ayurvedic clinical features such as Angamarda (body ache), Shirogaurav (heaviness in head), Jrimbha (yawning), Jadyata (sluggishness), Glani(fatigue), Bhrama (dizziness), and Apakti (indigestion) and Tandra (drowsiness).
6. Patients who are willing to participate in the clinical trial. |
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with any other psychiatric disorder who are on
medications that may cause sedation or affect sleep patterns.
2. Patients having Insomnia due to severe illness such as cardiac
diseases, hypertension, diabetes and other chronic disorders like
bronchial asthma, malignancies, liver diseases, chronic renal diseases
were excluded from the study.
3. Individuals in physiological conditions such as pregnancy, lactation, or
the postpartum (puerperal) stage.
4. Patients suffering from other medical conditions such as hypertension,
diabetes, or vertigo. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Asses Ashwagandha Leha and Nirgundi Taila Padabhyanga in Nidranash with special reference to Primary Insomnia on the assessment criteria of Nidranash after 15 days of treatment. |
0 day 7th Day 15th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
“A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT
OF ASHWAGANDHA LEHA AND NIRGUNDI TAILA PADABHYANGA IN
NIDRANASH WITH SPECIAL REFERENCE TO PRIMARY INSOMNIA” INTRODUCTION: Ayurveda emphasizes Nidra (sleep) as one of the three pillars of life (Trayopasthambha), essential for maintaining physical and mental health. Proper sleep brings balance, strength, nourishment, knowledge, and longevity, while disturbed sleep leads to Nidranash (insomnia), a Vata-dominant disorder affecting both mind and daily functioning. Classical texts describe its causes, symptoms, and treatments such as oil massage, foot massage, nourishing diet, and calming therapies to restore balanceInsomnia affects 10–30% of the global population and about 33% of adults in India, significantly impairing cognitive function, mood, work performance, and overall health. Conventional medicines often cause side effects, whereas Ayurveda offers a natural approach by restoring mind–body balance. Ashwagandha Leha promotes sleep by enhancing GABA activity in the brain, while Nirgundi Taila Padabhyanga helps pacify aggravated Vata, supporting natural and healthy sleep. SAMPLE SIZE: The sample size for the study will be 60 participants. Considering a 5% dropout rate for each group, the total sample size will be 70 participants. Null Hypothesis: Ashwagandha Leha and Nirgundi Taila Padabhyanga Is Not Effective in sign
and symptoms of Nidranash w.s.r. to Primary Insomnia Alternative Hypothesis :
Ashwagandha Leha and Nirgundi Taila Padabhyanga is effective in sign and
symptoms of Nidranash w.s.r. to Primary Insomnia. |