CTRI/2025/03/082599 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On:
28/02/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Ayurveda Preventive Behavioral
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Comaparative study of Vamana Karma and Nasya Karma followed by Satvavajaya Chikitsa with Yoga in Major depression.
Scientific Title of Study
Comparative study of Vamana Karma and Shirovirechana Nasya followed by Shamana Snehapana and Satwavajaya Chikitsa with Yoga in managing major depressive disorder- An Open Labelled Randomised Controlled Clinical Trial.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Akash Sharma
Designation
PhD Scholar
Affiliation
All India Institute of Ayurveda
Address
B 609, Kasturi Heights, Near RBK Global School, Eden Park, Indralok Phase 6, Bhayander East Panchakarma Dept, 7th Floor, C Block, All India Institute of Ayurveda, Sarita Vihar, New Delhi, Thane MAHARASHTRA 401105 India
Phone
07021184925
Fax
Email
aakusharma23@gmail.com
Details of Contact Person Scientific Query
Name
Dr Anandaraman PV
Designation
Professor and HOD of Panchakarma Department, AIIA, Delhi
Affiliation
HOD and Prof, Department of Panchakarma
Address
7th floor, Panchakarma department, C- Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi Panchakarma Dept, 7th Floor, C Block, All India Institute of Ayurveda, Sarita Vihar, New Delhi, New Delhi DELHI 110076 India
Phone
9495130595
Fax
Email
dr.ananthramsharma@gmail.com
Details of Contact Person Public Query
Name
Dr Akash Sharma
Designation
PhD Scholar
Affiliation
All India Institute of Ayurveda
Address
B 609, Kasturi Heights, Near RBK Global School, Eden Park, Indralok Phase 6, Bhayander East Panchakarma Dept, 7th Floor, C Block, All India Institute of Ayurveda, Sarita Vihar, New Delhi, Thane MAHARASHTRA 401105 India
Phone
07021184925
Fax
Email
aakusharma23@gmail.com
Source of Monetary or Material Support
All India Institute of Ayurveda
Primary Sponsor
Name
All India Institute of Ayurveda
Address
Gautampuri, Sarita vihar, New Delhi, Delhi-110076
Type of Sponsor
Government medical college
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Akash Sharma
All India Institute of Ayurveda
705, 7th floor, C Block, Gautampuri, Sarita Vihar, New Delhi, Delhi-110076 New Delhi DELHI
07021184925
aakusharma23@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee, All India Institute of Ayurveda
(Procedure Reference: Charak Samhita Chikitsa Sthan 9/26, Procedure details: •A washout period of 2 weeks will be given in case the patient is already taking allopathic medicine for any psychiatric illness. Allopathic medicines will be stopped during the course of entire treatment.
•Deepana –Pachana with Panchakola Churna given 3gm orally twice daily with lukewarm water for 7 days or until Nirama Lakshana.
•After assessing Nirama Lakshana, Snehapana will be given with Kalyanaka Ghrita in Arohana Matra starting with 30 ml and thereafter increasing the dose every day by calculating the time taken for digestion of Sneha for 7 days or until Samyaka Snigdha Lakshanas obtained.
•After assessing Samyaka Snigdha Lakshanas, for 1 days of Vishrama Kala, Sarvanga Abhyanga with Dhanvantara Taila and Sarvanga Vashpa Swedana with Dashmula Kwatha will be done.
•Vamana Karma will be done with Dhamargava Phala Churna with Punarnava Kwath Anupana in a dose of 6 gm after Sarvanga Abhyanga and Sarvanga Vashpa Swedana.
•After Vamana Karma, Samyaka Shodhana Lakshana will be assessed and Peyadi Samsarjana Karma will be followed as per Shuddhi.
•After completion of Samsarjana Karma, Shamana Snehapana with Kalyanaka Ghrita in a dose of 20ml daily morning at the time of breakfast on an empty stomach with lukewarm water as Anupana for 14 days.
•Patients will be advised to follow the Yoga protocol including Suryanamaskara, Ardha-Chakarasana, Ustrasana, Paschimottanasana, Bhujangasana, Pavanamukthasana, Viparithakarani, Shavasana, Kapalabhati, Suryanuloma-Viloma, Ujjayi, Bhastrika, Pranava Japa during Shamana Snehapana and the follow-up period also.
•2 follow ups will be taken at a gap of 15 days each. Yoga protocol will be continued during the follow up period.) (1) Medicine Name: Dhamargava Churna, Reference: Charak Samhita Kalpa Sthan 4/17-18, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Duration: 1 Days(2) Medicine Name: Kalyanaka Ghrita, Reference: Charak Samhita Chikitsa Sthan 9/33-41, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days
2
Intervention Arm
Procedure
-
nasyam/ nastam, नस्यम्/ नस्तम्
(Procedure Reference: Charak Samhita Chikitsa Sthan 9/27, Procedure details: •A washout period of 2 weeks will be given in case the patient is already taking allopathic medicine for any psychiatric illness. Allopathic medicines will be stopped during the course of entire treatment.
•Snehana Nasya with Kalyanaka Ghrita will be given in a dose of 10 Bindu (4.5ml) in each nostril for 7 days.
•After that, Shirovirechana Nasya with Jyotishmati Taila will be given in a dose of 8 Bindu (3.6ml) in each nostril for 7 days. Before Nasya Karma, Sthanika Abhyanga with Dhanvantara Taila and Sthanika Swedana with Dashamula Kwath will be done on head and neck region daily.
•After completion of Nasya Karma, Shamana Snehapana with Kalyanaka Ghrita in a dose of 20ml daily morning at the time of breakfast on an empty stomach with lukewarm water as Anupana for 14 days will be given.
•Patients will be advised to follow the Yoga protocol including Suryanamaskara, Ardha-Chakarasana, Ustrasana, Paschimottanasana, Bhujangasana, Pavanamukthasana, Viparithakarani, Shavasana, Kapalabhati, Suryanuloma-Viloma, Ujjayi, Bhastrika, Pranava Japa during Shamana Snehapana and the follow-up period also.
•2 follow ups will be taken at a gap of 15 days each. Yoga protocol will be continued during the follow up period. ) (1) Medicine Name: Jyotismati Taila, Reference: Ashtanga Hridaya, Uttara Sthan 6/26-31, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3.6(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: Kalyanaka Ghrita, Reference: Charak Samhita Chikitsa Sthan 9/33-41, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4.5(ml), Frequency: od, Duration: 7 Days(3) Medicine Name: Kalyanaka Ghrita, Reference: Charaka Samhita Chikitsa Sthan 9/33-41, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 14 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
50.00 Year(s)
Gender
Both
Details
Patients diagnosed with DSM-5 criteria for major depressive disorder.
Patients Yogya for Virechana, Nasya and Shamana Snehapana.
Patients irrespective of their sex, caste, or religion.
Newly diagnosed cases having chronicity less than 1 year.
ExclusionCriteria
Details
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1.Reduction in hamilton depression rating Score.
At baseline, 23rd day and on 45th day
Secondary Outcome
Outcome
TimePoints
1.Improvement in WHOQOL-BREF scale
2.Change in neurodegenerative biomarker level of serum neurofilament light chain.
At baseline, 23rd day & on 45th 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 4
Date of First Enrollment (India)
25/03/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
25/03/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="11" Days="30"
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 - YES
What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
Who will be able to view these files? Response - Anyone
For what types of analyses will this data be available? Response - For individual participant data meta-analysis.
By what mechanism will data be made available? Response (Others) - Data Obtained from this study will be published in a UGC listed and well recognised journal.
For how long will this data be available start date provided 16-07-2027 and end date provided 16-07-2031? Response - Immediately following publication. No end date.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
Major depressive disorder is a common and debilitating mental illness that is characterized by a depressed mood, appetite change, sleep disturbance, mental retardation or agitation, fatigue, guilt, loss of concentration, and suicidal ideation. Its worldwide prevalence is estimated at 4.4%.In India, it is estimated that nearly one-third of patients seeking help from healthcare facilities could have symptoms related to depression, and the crude prevalence rate of mood disorder was estimated to vary from as low as 0.5 to as high as 78 per 1000 population. Therefore in this study, VamanaKarma, ShirovirechanaNasya, ShamanaSnehapana and SatwavajayaChikitsa with Yoga is selected as the line of protocol for treating major depressive disorder. VamanaKarma can be done with DhamargavaPhalaChurna. Dhamargava is indicated as the best medicine for Vamana in psychiatric disorder. For ShirovirechanaNasya, Jyotishmati Taila will be used as it is indicated as Medhya and is also included in Shirovirechana Aushadhi.KalyanakaGhrita will also be used for ShadhanangaSnehapana, Snehana Nasya and also for ShamanaSnehapana. No previous study is available to evaluate the effect of the Panchakarma procedure on the neurofilament light chain. Hence this study is conducted to prepare an effective Ayurveda protocol to treat major depressive disorder and to show the effect on the neurofilament light chain.
Null Hypothesis-
H0- There is no difference between Vamana Karma and Shirovirechana Nasya followed by ShamanaSnehapana and SatwavajayaChikitsa with Yogaon hamilton depression rating scale in patients of major depressive disorder when measured with neurodegeneration biomarker neurofilament light chain.
Alternate Hypothesis-
H1–There is a difference between Vamana Karma and Shirovirechana Nasya followed by ShamanaSnehapana and SatwavajayaChikitsa with Yogaon hamilton depression rating scale in patients of major depressive disorder when measured with neurodegeneration biomarker neurofilament light chain.