| CTRI Number |
CTRI/2025/11/096806 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Shiv-Sankalp Suktam Mantra Chikitsa in Anxiety. |
|
Scientific Title of Study
|
Exploring the application of the Siddhanta Atra
Daivavyapashraymadavuttamam Aashu Vyadhihartven through
assessment of the adjunctive effect of Shiv-Sankalp Suktam in Chittodwega - An open label randomized trial. |
| 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. Khangar Shweta Yashwantrao |
| Designation |
PG Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room no-720,Department of Ayurveda Samhita evam Siddhant,7th
floor,Academic Block,All India Institute Of
Ayurveda,Gautampuri,Sarita Vihar,New Delhi,India
Room no-720,Department of Ayurveda Samhita evam Siddhant,7th
floor,Academic Block,All India Institute Of
Ayurveda,Gautampuri,Sarita Vihar,New Delhi,India
South
DELHI
110076
India |
| Phone |
8459125705 |
| Fax |
|
| Email |
shwetakhangar2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Vyas |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room no-720,Department of Ayurveda Samhita evam Siddhant,7th
floor,Academic Block,All India Institute Of
Ayurveda,Gautampuri,Sarita Vihar,New Delhi,India
Room no-720,Department of Ayurveda Samhita evam Siddhant,7th
floor,Academic Block,All India Institute Of
Ayurveda,Gautampuri,Sarita Vihar,New Delhi,India
South
DELHI
110076
India |
| Phone |
8849802005 |
| Fax |
|
| Email |
drmaheshkvyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Sharma |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room no-720,Department of Ayurveda Samhita evam Siddhant,7th
floor,Academic Block,All India Institute Of
Ayurveda,Gautampuri,Sarita Vihar,New Delhi,India
Room no-720,Department of Ayurveda Samhita evam Siddhant,7th
floor,Academic Block,All India Institute Of
Ayurveda,Gautampuri,Sarita Vihar,New Delhi,India
South
DELHI
110076
India |
| Phone |
8058282620 |
| Fax |
|
| Email |
nidhisharma04@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi .110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi.110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Khangar Shweta Yashwantrao |
All India Institute Of Ayurveda |
Screening opd (Opd no
16),Ground floor
,Hospital Block,All India
Institute Of Ayurveda
,Gautampuri,Sarita
Vihar,New
Delhi-110076
South
DELHI |
08459125705
shwetakhangar2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Mantra chikitsa | (Procedure Reference: शुक्ल यजुर्वेद ३४/१-६, Procedure details: The participants will be provided the pre-recorded Shiv-Sankalp Suktam.
• The participants will be advised to Listen the Sukta at evening.
• Sit in Sukhasana position, straighten the spine, close the eyes and relax the body.
• Repetition of Shiv-Sankalp Suktam 5 times. )
(1) Medicine Name: Bramhi Vati, Reference: Bramhi vati - Ayurved sar sangrah – Gutivati prakaran page no. 455-456., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 45 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bramhi Vati, Reference: Bramhi vati - Ayurved sar sangrah – Gutivati prakaran page no. 455-456, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Sukhoshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the criteria of GAD as per ICD 11 guidelines.
Hamilton anxiety score less than 28.
Age 18 to 42 years, irrespective to gender caste social economical care.
Individual who will be willing to give written consent. |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from any psychiatric disorder other than generalized anxiety disorder.
2. Individuals with other comorbidities like Epilepsy, Hypertension, Diabetes, Asthma,
Tuberculosis, Carcinoma, Schizophrenia, Psychosis, and any other severe illnesses.
3. Patient suffering from any major systemic disease requiring significant care.
4. Patient who are practicing another mantra chanting or meditation or counselling.
5. Patients with serious suicidal and homicidal risk, drugs or alcohol dependence.
6. Pregnant women and lactating mothers.
7. Patient not willing to participate in study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the symptoms of generalized anxiety disorder by using Hamilton Anxiety
Scale and Ayurveda Assessment Scale for Anxiety. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In detail review of Daivavyapashraya Chikitsa & Yuktivyapashraya Chikitsa. |
At the end of study |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 3 |
|
Date of First Enrollment (India)
|
12/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
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 - NO
|
|
Brief Summary
|
Ayurveda has always given due importance not only to the physical attributes but has laid equal emphasis to Psychological, Social and Spirituali aspects of life as well thus, ensuring both physical and mental wellbeing of an individual. Having holistic, humanistic and philosophical aspect Ayurveda have classified the Chikitsa or treatment modality to be of three types – Daivavyapashraya, Yuktivyapashraya and Satvavajaya chikitsa. ii 1. Daivavyapashraya chikitsa or spiritual therapy is a nonpharmacological treatment that is based on the use of Mantras, divine stones, auspicious offerings, Oblations, Atonement, Fasts etc.iii It is told first because of its Ashukaritva i.e. power to cure the diseases instantaneously and the mode of action can’t be ascertained through a general logic as it is beyond the purview of reasoning.iv 2. Yuktivyapashraya Chikitsa: based on Yukti or Rational thinking represents judicious use of an Aushadh in the form of tablets, decoctions, Aasavas, Arishtas, Panchakarmatherepies and Ahara as well.v 3. Satvavajaya Chikitsa:(Subjugation of mind/counselling) is also a non-pharmacological measure of treatment that includes all those methods of restraining or withdrawal of the mind from unwholesome objects to strengthen the satva or mind.vi One amongst the tools of Daivavyapashraya chikitsa includes use of Mantravii which is the most ancient. Its ample references are available in our ancient Vedas like Atharvaveda and Rigveda, Upanishadas and Aranyakas where it has been very clearly explained that proper chanting and even listening of Mantras or Sukta significantly reduces stress, calms down mind, controls negative thoughts, pauses negative actions by bringing harmony to mind. As the sound generated during Mantra produces vibrations that significantly influences the body, emotions and mental functioning.viii In present era’s metaphysical society is facing situation and everyday changing lifestyle. As a result, anxiety, depression, insomnia, stress related disorders and other mental illness are coming into existence Around 4.05% ixpopulation experiences anxiety disorder. Among whole population higher prevalence is in women and among younger adults. Unlike transient states of anxiety, General anxiety disorder is persistent, often occurring for at least six months or more, and can significantly impair daily functioning. In general anxiety disorder treatment like Cognitive Behaviour therapy (CBT), Mindfulness-based stress reduction (MBSR) and medications like selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs) and pregabalin, lifestyle modifications are advice. NEED OF THE STUDY: General anxiety disorder has a great impact on social, occupational and other functioning areas of the individual. The modern medical science have conventional treatment modalities are quite effective but sometimes work temporarily, and oral medications have shown drug dependence and many other side effects including constipation, dry mouth, and somnolence.x 19 Because of westernization in every aspect of Indian society from educational system to medicine, people believe only on those facts that can be perceived directly and explained scientifically. This eventually led to the degradation of Mantra Chikitsa or Daivavyapashraya Chikitsa procedures in the form of dying practices and has become the untouched part of treatment even being so effective and spontaneous in providing results so, there comes relevancy of exploration of new treatment modalities like Daivavyapashraya Chikitsa and Yuktivyapashraya Chikitsa mentioned in Ayurveda classics for the treatment So, an humble attempt has been done to find the effective management of general anxiety disorder through Daivavyapashraya Chikitsa and Yuktivyapashraya Chikitsa. Major research works had been conducted and have been done on Mantras like Gayatri Mantra, Om, Mahamrityunjay Mantra, Saurasukta, etc. However no major research has been performed to see the effect of Shiv Sankalp Suktam. however according to ancient scripts this Mantra has the ability to cure mental ailments. So keeping this in mind this study framework has been planned as an initial step to bring in a novel outlook for treating Anxiety patient. |