| 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
|
|
|
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
|
|
|
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 | Other 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. |