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CTRI Number  CTRI/2024/07/070240 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Combined effect of Saraswatha Churna internally and Thungadrumadi Taila externally on head in managing mild anxiety and depressive disorders 
Scientific Title of Study   A clinical trial to evaluate the combined efficacy of Saraswatha churna and Thungadrumadi taila in managing mixed depressive and anxiety disorder  
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 Arjun Chand C P 
Designation  Associate professor 
Affiliation  Pankajakasthuri Ayurveda Medical College and Post Graduate Centre 
Address  Department of Kayachikitsa Pankajakasthuri Ayurveda Medical College and Post Graduate Centre Kattakada Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  9495389767  
Fax    
Email  arjunchandcp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jayalakshmi Venugopal 
Designation  PG Scholar 
Affiliation  Pankajakasthuri Ayurveda Medical College and Post Graduate Centre 
Address  Department of Kayachikitsa Pankajakasthuri Ayurveda Medical College and Post Graduate Centre Kattakada Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  8943293929  
Fax    
Email  venusha.jaya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jayalakshmi Venugopal 
Designation  PG Scholar 
Affiliation  Pankajakasthuri Ayurveda Medical College and Post Graduate Centre 
Address  Department of Kayachikitsa Pankajakasthuri Ayurveda Medical College and Post Graduate Centre Kattakada Thiruvananthapuram

Thiruvananthapuram
KERALA
695572
India 
Phone  8943293929  
Fax    
Email  venusha.jaya@gmail.com  
 
Source of Monetary or Material Support  
Pankajakasthuri Ayurveda Medical College and PG Centre Kattakada Thiruvananthapuram Kerala Pin: 695572 
 
Primary Sponsor  
Name  NIL 
Address  NIL  
Type of Sponsor  Other [student funded MD project] 
 
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 
Jayalakshmi Venugopal  Pankajakasthuri Ayurveda Medical College and Hospital  OP Kayachikitsa Department Room No: H 06 Kattakada Thiruvananthapuram Kerala
Thiruvananthapuram
KERALA 
8943293929

venusha.jaya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC) Pankajakasthuri Ayurveda Medical College and PG Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F41||Other anxiety disorders. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Saraswatha churna, Reference: Bhavaprakasa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ghee, Honey), Additional Information: -
2Intervention ArmProcedure-Murdhni taila (Procedure Reference: Sushruta samhitha, Procedure details: 2ml of thungadrumadi taila is applied on the vertex of head in the evening and then wiped off after 10 minutes)
(1) Medicine Name: Thungadrumadi Taila, Reference: Sahasrayoga, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Subjects of age 18 – 40 years.
2.Subjects irrespective of gender and socio-economic status.
3.Subjects fulfilling ICD-11 criteria for Mixed Depressive and Anxiety Disorders.
 
 
ExclusionCriteria 
Details  1.Subjects scoring more than 17 in HAM-A.
2.Subjects scoring more than 20 IN HDRS.
3.Subjects taking medication for Depression/Anxiety/ other Psychiatric disorders.
4.Subjects who are known allergic to any of the ingredients.
5.Pregnant and lactating women.
6.Subjects with substance abuse.
7.Subjects with uncontrolled systemic disorders.
8.Subjects with violent behavior and self-harming actions and/or has suicidal ideations.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the combined efficacy of Saraswatha Churna and Thungadrumadi Taila in managing mixed depressive and anxiety disorder
2.To determine the combined efficacy of Saraswatha Churna and Thungadrumadi Taila in improving the emotional intelligence of an individual using SSEIT questionnaire
3.To determine the combined efficacy of Saraswatha Churna and Thungadrumadi Taila in improving the quality of life in an individual using WHOQOL questionnaire
 
Clinical assessment of symptoms of MDAD as per ICD-11 criteria, HAM-A, HDRS on 0th day, 16th day, 31st day and on 46th day
Serum cortisol at 8 am on 1st day and 31st day
Assessment of emotional intelligence using SSEIT score on 0th day and 46th day
Assessment of the quality of life in an individual using WHOQOL score on 0th day and 46th day

 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety of Saraswatha churna in subjects with Mixed Depressive and Anxiety Disorder  Blood Routine Examination with Erythrocyte Sedimentation Rate, Liver Function Test, Renal Function Test will be done on 0th day and 31st day

 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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 
Date of First Enrollment (India)   15/07/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 CLINICAL TRIAL TO EVALUATE THE COMBINED EFFICACY OF SARASWATHA CHURNA  AND THUNGADRUMADI TAILA IN MANAGING MIXED DEPRESSIVE AND ANXIETY DISORDER

Mental health is a crucial part of overall well-being, beyond just the absence of mental illnesses. It is essential for both individual happiness and optimal functioning. Anxiety and depression are the most prevalent mental health issues on a global scale. Mixed Depressive and Anxiety Disorder (MDAD) is a condition characterized by the presence of both anxiety and depression symptoms, occurring for at least two weeks on most days and these symptoms do not individually meet the diagnostic criteria for a distinct anxiety or depressive disorder.

MDAD can be corelated to Vishada in Ayurveda. Vishada is one among the Nanatmaja Vatavyadhis mentioned in Charaka Samhitha and may appear at any stage of life in a person. It affects a person with Avara Satva and Tamasika Guna. Even though Vishada is a psychological disorder mentioned in Ayurvedic texts, its detailed description is unclear, making diagnosis challenging. Many Ayurvedic researches have attempted to compare it with Generalized Anxiety Disorder (GAD) and Depression, but a concrete conclusion has been elusive. This study, tries to assess Ayurvedic and related literature alongside modern Psychology to determine the alignment between Vishada’s presentation and MDAD in terms of both psychological and somatic aspects.

This is a proposed interventional study with pre and post-test without control group. Subjects of both gender in the age group 18 to 40 years registered in the OPD of Pankajakasthuri Ayurveda Medical College and Post Graduate Centre Hospital, Kattakada, satisfying the inclusion criteria will be subjected to positive sampling and subjects will be selected for the study. Subjects will be enrolled into the study after necessary investigations from a recognized Standard laboratory and after assessment with HAM-A, HDRS, WHOQOL and SSEIT questionnaires. Dose and dosage regimens are fixed according to Ayurvedic classics.

In this study, Saraswatha Churna in a dosage of 6g with honey and ghee will be administered to the 26 subjects, orally twice daily before food, along with Thungadrumadi Taila as Murdhni Taila for 30 days. Saraswatha Churna serves as a cognitive enhancer with anxiolytic properties, improving memory while also possessing carminative attributes. Thungadrumadi Taila, on the other hand, is applied as a Tarpana treatment for the brain (Kapalamajja), a vital intervention along the Madhyama Roga Marga that addresses conditions with potential recurrence. Assessment will be done on 0th day, 16th day, 31st day and 46th day by using subjective and objective parameters. The results will be analyzed statistically and conclusion will be drawn.

 
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