| CTRI Number |
CTRI/2025/03/082765 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
comparison of shirodhara and shiroabhyanga using tila taila in generalised anxiety disorder |
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Scientific Title of Study
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A Randomized Comparative Clinical Trial of Shiro Dhara And Shiro Abhyanga with Tila Taila In Chittodvega With Special Reference To 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 |
Renuka Rajabhau Sulakhe |
| Designation |
PG Scholar MD Panchkarma |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor Panchkarma department PG Section MES Ayurved Mahavidyalaya Ghanekhunt Lote Khed Ratnagiri 415722
MAHARASHTRA
India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8888611065 |
| Fax |
|
| Email |
sulakherenuka123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vd Sachin Vasant Utpat |
| Designation |
Associate Professor |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor Panchkarma department PG Section MES Ayurved Mahavidyalaya Ghanekhunt Lote Khed Ratnagiri 415722
MAHARASHTRA
India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8411972626 |
| Fax |
|
| Email |
svu.phl@mespune.in |
|
Details of Contact Person
Public Query
|
| Name |
Renuka Rajabhau Sulakhe |
| Designation |
PG Scholar MD Panchkarma |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor Panchkarma department PG Section MES Ayurved Mahavidyalaya Ghanekhunt Lote Khed Ratnagiri
415722
MAHARASHTRA
India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8888611065 |
| Fax |
|
| Email |
sulakherenuka123@gmail.com |
|
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Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya and attached Parshuram Hospital and Research Center Ghanekhunt Lote Khed Ratnagiri 415722 Maharashtra India |
|
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Primary Sponsor
|
| Name |
Vd Renuka Rajabhau Sulakhe |
| Address |
MES Ayurved Mahavidyalaya Ghanekhunt Lote Khed Ratnagiri
Maharashtra India-415722 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| vd Renuka Rajabhau Sulakhe |
Parshuram Hospital & Research Center |
Panchkarma OPD Ghanekhunt Lote Khed Ratnagiri MAHARASHTRA Ratnagiri MAHARASHTRA
Ratnagiri
MAHARASHTRA |
8888611065
sulakherenuka123@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES Ayurved mahavidyalaya ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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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 | Comparator Arm | Procedure | - | shiro dhara | (Procedure Reference: dharakalpa 16, Procedure details: (Procedure Reference: dharakalpa 16, Procedure details: POORVAKARMA 1. Preparation of Patient - The supine position will be given to the patient for Shiro Dhara & Dhara Patra should be hold above 4 Angula on Forehead. The eyes & ear of the patient should be closed with the help of Gauze. 2. Temperature of Taila - Sukhoshna, nearly equal to body temperature. PRADHAN KARMA 1.Selected Medicated oil kept in the Dhara Patra & poured continuously, on not so fast & not so slow speed on forehead of the patient. 2. the flow of the oil will be adjusted with the stop cork or gauze piece by putting in inner side at its end 3 poured oil gathered in empty vessel & then reuse the oil. DURATION- 45 mins for 14 days. PERIOD TO CHANGE OIL-1.Oil should be changed after 3 days. Half the oil used for first 3 days & other Half used further 3 days First & Second half used oil mixed together on 7, Then oil should be discarded. d. PASCHAT KARMA Patients head should be dried & wiped out Rest & then lukewarm bath))
| | 2 | Intervention Arm | Procedure | - | shiro abhyanga | (Procedure Reference: dharakalpa 14, Procedure details: Procedure Reference: dharakalpa 14, Procedure details: POORVA KARMA Sukhoshna oil will be taken for Shiro Abhyanga Patients is fit in inclusion criteria will be taken . Procedure will be explained to the patient. consent will be taken. Ask patient to do mala mutra visarjana PRADHAN KARMA 1.The Shiroabhyanga is one among the Bahirparimarjana Chikitsa 2. we will give patient comfortable position for treatment. 3.by using Sukhoshna Tila Taila Shiroabhyanga will be done. 5.It is carried out by using tip of the fingers gently massage over the Scalp, shoulder & the neck region too. DURATION OF TREATMENT- 10 MIN FOR 14 DAYS PASCHAT KARMA Short duration of massage & rest then lukewarm bath. ))
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Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who are diagnosed with Chittodvega (Generalised Anxiety Disorder) with DSM V Diagnostic criteria.
2 Patients who are not suffering any other psychiatric disorder.
3 Patients in the age group 17-60 year.
4 Patients who are not on any other medication for the same disease.
5 Patients who are indicated for Shiro Dhara and Shiro Abhyanga.
6 Informed consent of willingness of patient. |
|
| ExclusionCriteria |
| Details |
1.Patients on any other medication on Chittodvega.
2.Patients who are below age group 17 and above 60.
3.Patients who are contraindicated for Shiro Dhara and Shiro
Abhyanga.
4.Patients who are not diagnosed with DSM V criteria
5.Patients who are suffering from any other psychiatric disorder. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Shiro Abhyanga more and equally effective than Shiro Dhara with Tila Taila in reducing symptoms of Chittodvega(Generalised Anxiety Disorder) |
7 days intervention with follow up on 7th and 14 th day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Shiro Abhyanga with Tila Taila is less effective than Shiro Dhara with Tila Taila in the management of Chittodvega (Generalised Anxiety Disorder)
|
7 days intervention with follow up on 7th and 14 th day |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="30"
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)
|
18/04/2025 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Tittle - A Randomized Comparative Clinical Trial of Shiro Dhara and Shiro Abhyanga with Tila Taila in Chittodvega With Special Reference To Generalised Anxiety Disorder.”
Background and purpose of study-
This study aims to compare the effects of Shirodhara and Shiro Abhyanga with Tila Taila on Chittodvega, focusing on Generalized Anxiety Disorder (GAD). The goal is to assess the effectiveness of these Ayurvedic treatments in reducing anxiety symptoms and improving mental well-being, with evidence from a randomized clinical trial.
Hypothesis -Shiro Abhyanga is more or equally effective than Shiro Dhara with Tila Taila in the management of Chittodvega (Generalised Anxiety Disorder).
Null hypothesis -Shiro Abhyanga with Tila Taila is less effective than Shiro Dhara with Tila Taila in the management of Chittodvega (Generalised Anxiety Disorder).
STUDY DESIGN This study employs a randomized comparative clinical trial design.
INCLUSION CRITERIA
1. Patients who are diagnosed with Chittodvega (Generalised Anxiety Disorder) with DSM V [8] Diagnostic criteria. 2. Patients who are not suffering any other psychiatric disorder. 3. Patients in the age group 17-60 year. 4. Patients who are not on any other medication for the same disease. 5. Patients who are indicated for Shiro Dhara and Shiro Abhyanga. 6. Informed consent of willingness of patient.
EXCLUSION CRITERIA
1.Patients on any other medication on Chittodvega. 2.Patients who are below age group 17 and above 60. 3.Patients who are contraindicated for Shiro Dhara and Shiro Abhyanga. 4.Patients who are suffering from any other psychiatric disorder.
sample size 60 (30 for each group)
patient coming to opd and ipd of our hospital
SAMPLING TECHNIQUE
Simple random sampling (lottery).
1.Group A- (Shiro Abhyanga): 30 Participants receive Shiro Abhyanga therapy using Tila Taila.
2.Group B- (Shiro Dhara): 30 Participants receive Shiro Dhara therapy using Tila Taila.
DURATION OF TREATMENT -14 DAYS.
FOLLOW UP 14th day
Result- Result will be drawn as per assessment criteria and statistical analysis
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