| CTRI Number |
CTRI/2025/07/091791 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of two Ayurvedic drugs and a ayurvedic procedure in common in reducing anxiety symptoms.
|
|
Scientific Title of Study
|
A Clinico-Comparative Study to Evaluate the Efficacy of Brahmyadi Ghanavati with Shirodhara and Medhya Rasayana Ghanavati with Shirodhara in the Management of Chittodvega (Anxiety Neurosis) |
| 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 Ayushi Chandil |
| Designation |
Post graduate resident |
| Affiliation |
Pt khushilal sharma govt (Auto) ayurveda college and institute |
| Address |
room no 221 PG department of kayachikitsa of Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh
PG department of kayachikitsa of Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7000519477 |
| Fax |
|
| Email |
chandilayushi72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Meshram |
| Designation |
Proffessor and HOD |
| Affiliation |
Pt khushilal sharma govt (Auto) ayurveda college and institute |
| Address |
PG department of kayachikitsa of Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh
PG department of kayachikitsa of Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425024816 |
| Fax |
|
| Email |
dr.rajeshmeshram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi Chandil |
| Designation |
Post graduate resident |
| Affiliation |
Pt khushilal sharma govt (Auto) ayurveda college and institute |
| Address |
room no 221 PG department of kayachikitsa of Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh
PG department of kayachikitsa of Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7000519477 |
| Fax |
|
| Email |
chandilayushi72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh |
|
|
Primary Sponsor
|
| Name |
Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh |
| Address |
PG department of kayachikitsa of Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh |
| Type of Sponsor |
Government funding agency |
|
|
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 Ayushi Chandil |
Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh |
room no 221 PG department of kayachikitsa of Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh
PG department of kayachikitsa of Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh
Bhopal
MADHYA PRADESH |
07000519477
chandilayushi72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee Pt khushilal sharma govt (Auto) ayurveda college and institute bhopal madhya pradesh |
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, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Astanga Hridayam, Sutra sthana, Chapter 17, Procedure details: The patient will lie in supine position and parishek sweda(Shiro-dhara) will be done on shiro pradesh by Koshna Kwath )
(1) Medicine Name: Mansyadi Kwath, Reference: Yadavaji Trikamji. Siddha Yoga Sangraha, 8th ed. Nagpur: Shri Baidyanatha Ayurveda Bhavan Ltd; 1984 Pp 580, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmyadi ghanavati, Reference: Sharangdhar Samhita by Dr.Bhramanand Tripathi Hindi edition 2019 Pp 130 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: koshana jala), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Medhyarasayan ghanavati, Reference: Chakrapani. Charaka Samhita (Ayurveda Deepika Commentary), Chikitsa sthan 1/3. Varanasi: Chaukamba Orientalia; 2023 Pp 55, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: koshana jala), Additional Information: - | | 4 | Comparator Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Astanga Hridayam, Sutra sthana, Chapter 17, Procedure details: The patient will lie in supine position and parishek sweda(Shiro-dhara) will be done on shiro pradesh by Koshna Kwath )
(1) Medicine Name: Mansyadi Kwath, Reference: Yadavaji Trikamji. Siddha Yoga Sangraha, 8th ed. Nagpur: Shri Baidyanatha Ayurveda Bhavan Ltd; 1984 Pp 580, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 14 Days |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling the diagnostic criteria for GAD as per ICD 10 F 41.1.
2.Patients with score between 17–24 on Hamilton’s Anxiety Rating Scale.
3.Patient willing to sign the consent form for participation in this study
|
|
| ExclusionCriteria |
| Details |
1.Patients who are known case of major psychological disorders like Schizophrenia, Bipolar disorder etc.
2.Patients who are known case of advanced chronic illnesses like Bronchial asthma, Diabetes, any type of Malignancy, Chronic Renal failure, acute illness like CVA, MI,and Hormonal imbalance.
3.Pregnant women and lactating mothers.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of study, scholar will be able to evaluate the efficacy of Brahmyadi ghanavati with shirodhara & Medhyarasayan ghanavati with shirodhara in the management of Chittodvega [Anxiety Neurosis]. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of study, scholar will be able to evaluate and explain the efficacy of Brahmyadi ghanavati with shirodhara & Medhyarasayan ghanavati with shirodhara in the management of Chittodvega [Anxiety Neurosis]. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/08/2025 |
| 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="0"
Days="0" |
|
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
|
It is expected that at the end of study, we will be able to demostrate the efficacy of Brahmyadi ghanavati with shirodhara & Medhyarasayan ghanavati with shirodhara in the management of Chittodvega [Anxiety Neurosis]. |