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CTRI Number  CTRI/2024/05/066782 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 07/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical investigation to Evaluate the Efficacy and Safety of antistress formulation in Managing Anxiety Disorder. 
Scientific Title of Study   An open clinical trial to evaluate the efficacy of Pankajakasthuri antistress formulation in the management of patients diagnosed with generalized anxiety disorder 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
PHRF /IEC/20/2024 version 1 dt 15th Jan 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrJHareendran Nair  
Designation  Managing Director and Founder  
Affiliation  Pankajakasthuri Herbal research Foundation  
Address  Roon NO: 1 Department of Kaya Chikitsa Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum Thiruvananthapuram KERALA 695572 India

Pathanamthitta
KERALA
695572
India 
Phone    
Fax    
Email  hareendrannair@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shan Sasidharan 
Designation  Director 
Affiliation  Pankajakasthuri Herbal Research Foundation 
Address  Roon No: 1 Department of R&D Pankajakasthuri Ayurveda Medical College Campus, Killy, Kattakada, Kerala, India,

Thiruvananthapuram
KERALA
695572
India 
Phone  09188325339  
Fax    
Email  drshan@pkhil.com  
 
Details of Contact Person
Public Query
 
Name  Shan Sasidharan 
Designation  Director 
Affiliation  Pankajakasthuri Herbal Research Foundation 
Address  Roon No: 1 Department of R&D Pankajakasthuri Ayurveda Medical College Campus, Killy, Kattakada, Kerala, India,


KERALA
695572
India 
Phone  09188325339  
Fax    
Email  drshan@pkhil.com  
 
Source of Monetary or Material Support  
Pankajakasthuri Herbals India Pvt. Ltd, Poovachal, Thiruvananthapuram, Kerala, India Pin 695575  
 
Primary Sponsor  
Name  Pankajakasthuri Herbals India Pvt Ltd P  
Address  Poovachal, Thiruvananthapuram, Kerala, India 69575  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Dr Arjun Chand CP  Pankajakasthuri Ayurveda Medical College & PG Centre   Department of kayachikitsa Room No.1A PankajakasthuriAyurveda MedicalCollege & PG Centre,Killy, Kattakada,Thiruvananthapuram, Thiruvananthapuram KERALA Thiruvananthapuram KERALA
Thiruvananthapuram
KERALA 
9495389767

arjunchandcp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation  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 ArmDrugOther than Classical(1) Medicine Name: Pankajakasthuri Antistress capsules, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 800(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: Capsule should be taken along with luke warm water
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of either gender in the age group between 18 -60 years
2. Diagnosed as per ICD 10 criteria
3. Patients having Symptoms of GAD
4. Willing to enrol in study by signing Informed consent
 
 
ExclusionCriteria 
Details  Earlier participation in this study
2. Patients having other systemic diseases not under control
3. Patients who are not willing to sign the informed consent form
4. Patients who are diagnosed with Organic brain syndrome
5. Subjects with un controlled Endocrine disorders
6. Unable to respond properly for questionnaire or when a patient is too severely ill to answer the questions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Pankajakasthuri antistress formulation in Hamilton Anxiety Rating scale parameters, Cortisol and GSR BIOFEEDBACK.
Any incidents of adverse events after the administration of Pankajakasthuri antistress formulation
Any marked change in safety parameters (like LFT, RFT) measured during the administration of the product.
 
The efficacy parameters including Hamilton anxiety rating scale, S. cortisol and GSR Biofeedback; safety parameters including LFT, RFT will be assessed on Base line, 4th week, 12th week and 24th week. 
 
Secondary Outcome  
Outcome  TimePoints 
Additional therapeutic advantages of Pankajakasthuri antistress formulation
Effect of Pankajakasthuri antistress formulation in quality of life
 
Quality of life Assessment will be assessed on 0th day, 30th day, 90th day and 180th day  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   14/05/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Generalized Anxiety Disorder (GAD) is a prevalent mental health condition characterized by excessive worry and anxiety. Despite the availability of pharmacological interventions, many individuals seek complementary and alternative treatments due to concerns about side effects and the desire for more holistic approaches. Pankajakasthuri Antistress Formulation (PAF), a herbal formulation for its anxiolytic properties. However, its efficacy in GAD management has not been extensively studied in clinical settings. This study aims to assess the efficacy of Pankajakasthuri Antistress Formulation as an adjunctive therapy in the management of patients diagnosed with Generalized Anxiety Disorder. An open-label clinical trial will be conducted involving patients diagnosed with GAD according to DSM-5 criteria. Participants will receive Pankajakasthuri Antistress Formulation as an adjunct to standard pharmacotherapy or psychotherapy for a duration of 12 weeks. Outcome measures including changes in anxiety symptoms, quality of life, and adverse effects will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks using standardized psychometric scales such as the Hamilton Anxiety Rating Scale (HAM-A) and the Generalized Anxiety Disorder 7-item Scale (GAD-7). This open clinical trial will provide valuable insights into the potential role of Pankajakasthuri Antistress Formulation as an adjunctive therapy in the management of Generalized Anxiety Disorder. If found effective and well-tolerated, PAF could serve as a promising alternative or complementary treatment option for individuals with GAD, contributing to the broader spectrum of available therapeutic interventions for this prevalent mental health condition.

 
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