| CTRI Number |
CTRI/2022/07/043928 [Registered on: 12/07/2022] Trial Registered Prospectively |
| Last Modified On: |
08/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to study the effect of Dashmoola taila Nasya and Shirodhara in headache |
|
Scientific Title of Study
|
A Comparative study of Dashmoola taila Nasya and Shirodhara in Vatika Shiroroga(Tension Headache) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Kumar Sharma |
| Designation |
Professor |
| Affiliation |
Rishikul Campus UAU Haridwar |
| Address |
Department of Panchakarma Rishikul Campus Haridwar Uttarakhand Ayurved University Kripayanam Gandhi road Kankhal Opposite telephone exchange Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9758264264 |
| Fax |
|
| Email |
kripayanam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Kumar Sharma |
| Designation |
Professor |
| Affiliation |
Rishikul Campus UAU Haridwar |
| Address |
Department of Panchakarma Rishikul Campus Haridwar Uttarakhand Ayurved University Kripayanam Gandhi road Kankhal Opposite telephone exchange Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9758264264 |
| Fax |
|
| Email |
kripayanam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Sharma |
| Designation |
MD Scholar |
| Affiliation |
Rishikul Campus UAU Haridwar |
| Address |
Department of Panchakarma Rishikul Campus Haridwar Uttarakhand Ayurved University Dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9813870455 |
| Fax |
|
| Email |
sakshi0455@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, UAU Haridwar |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University Harrawala Dehradun |
| Type of Sponsor |
Government 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 |
| Sakshi Sharma |
OPD & IPD in Rishikul campus |
Department of Panchakarma Rishikul Campus Haridwar
Hardwar
UTTARANCHAL |
9813870455
sakshi0455@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: Vatika Shiroroga , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Nasya | (Procedure Reference: Charaka samhita (chikitsa sthana 26/158), Procedure details: Patients will be treated with Dashmoola Taila Nasya for 7 days. Total 3 sittings of Nasya with 3 days gap in between each sitting)
(1) Medicine Name: Dashmoola taila, Reference: Bhaishajya ratnawali 65/65-70, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 27 Days | | 2 | Comparator Arm | Procedure | - | Shirodhara | (Procedure Reference: Ashtang Hridya uttar sthan 24/1-3, Procedure details: Patients will be treated with Dashmoola Taila Shirodhara for 7 days. Total 3 sittings of Shirodhara with 3 days gap in between each sitting.)
(1) Medicine Name: Dashmoola taila, Reference: Bhaishajya ratnawali 65/65-70, Route: Topical, Dosage Form: Taila, Dose: 1500(ml), Frequency: od, Duration: 27 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having sign and symptoms of Vatika Shiroroga (Tension Headache)
2.Patient fit for Nasya
3.Patient fit for Shirodhara |
|
| ExclusionCriteria |
| Details |
1.Known case of Sinusitis
2.Any other types of infection associated with fever
3.Any pathology involving the eyes
4.Uncontrolled Hypertension
5.Diabetes mellitus
6.Migraine, Cluster headache, Trigeminal neuralgia
7.Known case of Seizures
8.Any other serious systemic illness
9.Secondary headache arising due to meningitis, tumor, cervical spondylosis etc.
10.Nasya and Shirodhara ayogya patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
NO improvement: 0-25%
Mild improvement: 26-50%
Moderate improvement: 51-75%
Marked improvement: 76-100% |
0,7th, 14th,27th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exacerbation in signs and symptoms |
27days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/07/2022 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Charaka has considered Shirah as the supreme important and major part of the body which is known as the Uttamanga. The Vata pradhan Tridoshaj Nidan causes the vitiation of Vata dominent Tridosha which enters in the Shirah Pradesh and manifest the symptoms of Vatika Shiroroga.Tension Headache is one such psycho somatic disease which can be compared with the Vatika Shiroroga described in Ayurvedic texts. According to IHS ,globally, prevalence of Tension type Headache 42%. As quite a big number of people suffer from this disease, innumerable analgesics have been added to the arsenal of the modern physician, aftermath of which are that they are having serious side effect. Therefore, search for a safer management is of great importance. The Nasika is said to be the gateway of the Shirah ,thus is the best route to eliminate the Doshas of the Shirah. Hence Nasya therapy is of primary importance in the treatment of the Shirorogas. Also, Shirodhara is one of the allied Panchakarma procedures, which calm the mind and relaxes entire physiology. Beneficial action of Shirodhara in the management of Vatika Shiroroga has been reported. The efficacy of the "Dashmoola Taila" in all Shiroroga is well known as mentioned in the Bhaishajya ratnawali. Vata Dosha is responsible for pain (Shoola). So, to evaluate the efficacy of Dashmoola Taila Nasya in Vatika Shiroroga (Tension Headache) and to evaluate the efficacy of Dashmoola Taila Shirodhara in Vatika Shiroroga (Tension Headache) and to compare the efficacy of Dashmoola Taila Nasya and Dashmoola Taila Shirodhara in Vatika Shiroroga trial is to conducted. |