| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F41||Other anxiety disorders. Ayurveda Condition: VISHADAH/DINATAÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Procedure | - | 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
|
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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. |