| CTRI Number |
CTRI/2026/04/108138 [Registered on: 10/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Assess The Efficacy Of Mandukparni Siddhataila Shirobasti In Vishada (Depression) |
|
Scientific Title of Study
|
Clinical Trial For Assessing The Efficacy Of Mandukparni Siddhataila Shirobasti in The Management Of Vishada (Depression) |
| 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 Shivam Ramkishan Parihar |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyala And Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved
Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad
Maharashtra India 431011
Aurangabad MAHARASHTRA 431011 India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8668736404 |
| Fax |
|
| Email |
shivamparihar121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Keshavrao Neralkar |
| Designation |
Professor |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyala And Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved
Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad
Maharashtra India 431011
Aurangabad MAHARASHTRA 431011 India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9850035061 |
| Fax |
|
| Email |
uneralkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam Ramkishan Parihar |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyala And Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved
Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad
Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8668736404 |
| Fax |
|
| Email |
shivamparihar121@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 15 C.S.M.S.S Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad Maharashtra |
| Address |
OPD No 15 Panchakarma Department CSMSS Ayurved
Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad
Maharashtra India 431011
Aurangabad MAHARASHTRA 431011 India |
| 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 Shivam Parihar |
C.S.M.S.S Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad Maharashtra |
OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved
Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad
Maharashtra India 431011
Aurangabad MAHARASHTRA 431011 India
Aurangabad
MAHARASHTRA |
8668736404
shivamparihar121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS AYURVED MAHAVIDYALAYA AND RUGNALAYA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F439||Reaction to severe stress, unspecified. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sneha-bastiH, स्नेह-बस्तिः | (Procedure Reference: CHA.CHI 1/30, Procedure details: Purvakarma
abhyanga and swedana will be done before the shirobasti
Ears will be covered with cotton pad to avoid entry of oil in ear
Eyes will be lightly bandaged so that the liquid may not enter the eyes of the patients.
Procedure
The patients should be properly seated on the armed table.
Take two strips of cloths, smear one side with the paste of black gram, it should be tight enough to prevent leaking of the oil.
Readymade shirobasti yantra should be fixed over the strap and junctions of shirobasti yantra are sealed with black gram paste.
Medicated oil should be warmed just above body temperature and poured it into shirobasti yantra with a strip of cloth.)
(1) Medicine Name: MANDUKPARNI TAILA, Reference: CHA.CHI 1/30, Route: Topical, Dosage Form: Taila, Dose: 1500(ml), Frequency: sos, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Dignosed patients of vishada (Depression) having clinical features like Dukkhtvam
Nidravaishamya, Manah khedah Chittodvega Asiddhi bhaya Anabhiruchi
Age cadre 18 to 50 years
Patients of either gender, irrespective of socioeconomic status
Patient willing to sign the informed consent form
Patient with history of Vishada (Depression) less than one year |
|
| ExclusionCriteria |
| Details |
Patient age group of below 18 and above 50 years
Shirobasti ayogya
Patient which are not willing to do shirobasti
Patient with major depressive disorder
Pregnant women and children
Patients with chronic illness like Cancer Hypertension Diabetes Mellitus
Hyperthyroidism and Hypothyroidism
Patients with Suicidal tendency and thoughts |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Chittodvega (Anxiety)
Anabhiruchi (Loss of Interest)
Nidravaishamya (Sleep disturbances) |
0 and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dukkhatvam (Feeling of sadness or depressed mood)
Manah khedah (Inappropriate guilt)
Asiddhi bhaya( Fear of failure to perform) |
0 & 15th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2026 |
| 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
|
Depression continues to be one of the leading causes of disability worldwide The World Health Organization WHO reports that over 300 million people suffer from depression globally and despite the availability of pharmaceutical treatments many individuals do not find sufficient relief or experience significant side effects Limitations of Conventional Treatment Current antidepressants although effective for some come with significant limitations such as delayed onset of action side effects like weight gain sexual dysfunction and cognitive impairment as well as the risk of relapse after discontinuation This highlights the need for alternative therapies that are safe natural and effective The Role of Ayurveda in Mental Health Ayurveda with its holistic approach to health emphasizes the balance of body mind and spirit Mandukparni is a herb recognized for its adaptogenic and nootropic properties It is believed to improve cognitive function reduce anxiety and stabilize mood, making it an ideal candidate for treating depression Siddhataila a medicated oil is traditionally used in therapeutic procedures like Shirobasti to balance the doshas and restore mental harmony |