| CTRI Number |
CTRI/2025/09/094713 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing How an Ayurvedic Nose Therapy with Balashwagandhadi tail Can Help with Anxiety |
|
Scientific Title of Study
|
Clinical Evaluation of Balashwagandha Taila Nasya in Chittodvega (Generalised 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 |
Priyanka Mittal |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1, UTTARANCHAL |
| Address |
Panchakarma Department Opd no.4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand Haridwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9759568583 |
| Fax |
|
| Email |
13pm1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Piyush Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1, UTTARANCHAL |
| Address |
Panchakarma Department Opd no.4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand Haridwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8954890277 |
| Fax |
|
| Email |
drpiyushgupta3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Mittal |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1, UTTARANCHAL |
| Address |
Panchakarma Department Opd no.4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand Haridwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9759568583 |
| Fax |
|
| Email |
13pm1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand 249405 India |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand 249405 India |
| Type of Sponsor |
Private medical college |
|
|
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 Priyanka Mittal |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
Department of Panchakarma,OPD no.4, phase 1
Hardwar
UTTARANCHAL |
9759568583
13pm1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Ayurveda College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtang Hridya Sutra Chapter 20 Shloka 17-20, Procedure details: Procedure Reference: , Procedure details: Poorva Karma:After passing feaces, urine & attended daily regimens like Dantadhavana(Brushing the tooth) the patient is advocated with Abhyanga & Swedan on Shira(Urdhvajatrugata) for liquefaction of Dosha. Patient made to lie in supine position with Pravilambita Shira(head lowered) & legs slightly raised. Pradhan Karma: The oil to be administer is made Sukhoshna.Then Vama Pradeshni(left index finger) is used to raise the tip of the patient nose,then lukewarm oil is instilled into one or both nostrils with Dakshina Hasta(right hand). Paschat Karma: Patient should lie in supine position for 100 Matra kala. After administration of Nasya , the regions of ear, forehead, scalp, cheek, nape of neck, shoulder, palm, sole are massaged. Patient is asked to spit out the medicine. Medicated Dhumpana is advised to expel out the residual Doshas. Patient is asked to avoid dust, smoke, sunshine, head bath, anger, riding. Nasya will be given for 7 days.Follow up will be taken after 1 month )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient with age group of 18-70 years,
2)Patient of any socio-economic status and any gender.
3)Patients fit for Nasya Karma.
4)Patient who score at least 14 on Hamilton anxiety rating scale.
|
|
| ExclusionCriteria |
| Details |
1)The age less than 18 and the age greater than 70 years.
2)Patient with uncontrolled Diabetes Mellitus, Hypertension and malignancies.
3)Pregnant & lactating women.
4)Patients unfit for Nasya Karma.
5)Patients with any other mental disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Shirah shoonyata.
2)Chakshushorakulta
3)Ucchwasasyadhikyam
4)Udvega
5)Dhyana
6)Hridgraha
7)Ayasa
8)Unmattchittatvam
9)Anannabhilasa
10)Sammoha
11)Avipaka
Hamilton Anxiety Rating scale |
7.30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CBC
ESR
RBS
TSH |
7,30 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/09/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
This Study is Clinical Evaluation of Balashwagandhadi Taila Nasya in Chittodvega (Generalised Anxiety Disorder) This will be conducted on 60 randomly selected patients from OPD/IPD of Panchakarma Department of Patanjali Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patient will be in one group. All patients will be given Nasya with Balashwagandhadi Taila for 7 days. Follow up will be taken after 1 month. Assessment to be done on the basis of subjective and objective parameters as discussed earlier. |