| CTRI Number |
CTRI/2025/08/092175 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Open-Label Clinical Study Involving 10 Participants to Evaluate the Therapeutic Effect of Virechana Followed by Yastimadhu Rasayana on Neurotransmitters and Skin Condition Considering the Prevalence of Psycho dermatological Manifestations. |
|
Scientific Title of Study
|
An Open-Label Clinical Study to Evaluate the Therapeutic Effect of Virechana Followed by Yastimadhu Rasayana on Neurotransmitters in Psycho dermatological Skin Manifestations. |
| 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 Manisha U K |
| Designation |
MD Scholar (Manasaroga). |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi. |
| Address |
OPD-3, Department of Manovijnana avum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
8296362917 |
| Fax |
|
| Email |
manuuday1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhaneshwari H A |
| Designation |
B.A.M.S., M.D. (Ayu), Assistant Professor in the Department of Kayachikitsa and Manasaroga. |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda |
| Address |
OPD-3, Department of Manovijnana avum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9900554202 |
| Fax |
|
| Email |
drdhaneshwarisdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhaneshwari H A |
| Designation |
B.A.M.S., M.D. (Ayu), Assistant Professor in the Department of Kayachikitsa and Manasaroga. |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda |
| Address |
OPD-3, Department of Manovijnana avum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9900554202 |
| Fax |
|
| Email |
drdhaneshwarisdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Govt. of India.
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homeopathy Anusandhan Bhawan
61-65, Institutional Area, Opp.D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Ministry of AYUSH, Govt. of India, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Manisha U K |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
OPD-3, Department of Manovijnana avum Manasaroga, Kuthpady
Udupi
KARNATAKA |
8296362917
manuuday1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee-Human, Sri Dharmasathala Manjunatheshwara College Of Ayurveda, Hospital And Research Centre, Kuthpady, Udupi. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F459||Somatoform disorder, unspecified. Ayurveda Condition: MANA-SANTAPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu, Reference: 7. Acharya Y T, editor, (1st ed.). (2013). Charaka Samhita of Agnivesha. Chikitsasthana; Kshataksheena chikitsa: Chapter 11, Verse 91-92, Varanasi: Chaukhambha Prakashan. , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling diagnostic criteria
2.Patients with age group between 18-60 years
3.Patient willing to sign informed consent.
4.Patient fit for Virechana karma.
|
|
| ExclusionCriteria |
| Details |
1.Patients with any other systemic illness interfering with the present treatment.
2.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the therapeutic effect of Virechana followed by Yastimadhu Rasayana on
1.Level of Neurotransmitter
2.Hamilton rating scale.
3.Specific skin assessment scale.
|
0th day
17th (+/-5) day
47th (+/-4) day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 4 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This open-label interventional study aims to evaluate the therapeutic effect of Virechana followed by Yastimadhu Rasayana on neurotransmitter levels, particularly serum serotonin, in patients with psychodermatological skin manifestations. The protocol includes Deepana-Pachana, Snehapana, Abhyanga, and Virechana as part of the preparatory and main procedures, followed by administration of Yastimadhu Rasayana. Ten participants aged 18 to 60, diagnosed with psychiatric conditions such as stress, anxiety, or depression with associated skin disorders, will be assessed. Outcome measures include changes in serum serotonin levels, Hamilton Rating Scale scores, and specific dermatological scales. The study aims to provide an integrative Ayurvedic approach to managing psychodermatological conditions by targeting both mind and body through detoxification and rejuvenation therapies. |