| CTRI Number |
CTRI/2023/07/055786 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess the efficacy of Shadbindu oil in management of Unilateral headache. |
|
Scientific Title of Study
|
A critical study on “ Nasa hi shiraso dwaram†and its applied anatomy with special reference to Ardhavabhedaka |
| 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 Nishant Kumar |
| Designation |
MD Scholar |
| Affiliation |
Banaras hindu university |
| Address |
Department of Rachana sharir, Faculty of ayurveda IMS BHU Varanasi, Uttar Pradesh
Pin- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9473533848 |
| Fax |
|
| Email |
nishant.kumar886@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Kumar |
| Designation |
MD Scholar |
| Affiliation |
Banaras hindu university |
| Address |
Department of Rachana sharir,Faculty of ayurveda IMS BHU Vaaranasi, 221005 Varanasi,Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9473533848 |
| Fax |
|
| Email |
nishant.kumar886@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Kameshwar Nath Singh |
| Designation |
Professor |
| Affiliation |
Banaras hindu university |
| Address |
Department of Rachana sharir,Faculty of ayurveda IMS BHU Vaaranasi, 221005 Varanasi,Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839049183 |
| Fax |
|
| Email |
knsingh08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital BHU VARANASI OPD No- 16 C |
|
|
Primary Sponsor
|
| Name |
Dept of PanchakarmaFaculty of AyurvedaInstitute of Medical Science |
| Address |
Institute of Medical Science Banaras Hindu University ,Varanasi, 221005 |
| 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 |
| Dr Nishant Kumar |
Sir Sundalal Hospital |
Department Of Panchakarma OPD No.16 C Indian Medicine Wing Faculty Of Ayurveda wing
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9473533848
nishant.kumar886@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G939||Disorder of brain, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shadbindu Taila, Reference: Ayurveda Saar Sangraha, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Normal Saline | two drops of normal saline administered to each nostrils as a placebo drug |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with sign and symptoms of Ardhavabhedaka
2.Patients who are fit for Nasya karma according to Ayurveda text books.
3.Willing to complete daily diary
4.Willing to take the medication for 30 days |
|
| ExclusionCriteria |
| Details |
1. Major medical illness under treatment
2. Pregnancy
3. High blood pressure/low blood pressure
4. Use of any other alternative medication during the study period
5. Patient not willing to give his/her consent
6. Patient suffering from secondary causes of headache |
|
|
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 |
Relief in sign & symptoms of the disease. The
main sign & symptoms in the study are as
follows:
Severity of Headache
Frequency of Headache
Duration of Headache
Nausea
Vomiting |
30 days study with follow-up at 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
eduction in scoring of following scales1 Migraine Disability Assessment Score
2 Visual Analog Scale
|
30 days study with follow-up at 15 days |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| 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 Applicable |
| 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
|
46 cases of Ardhavabhedaka will be included in this interventional study which will be randomly
divided into 2 groups of 23 patients in each group. One group will be prescribed Shadbindu Taila. Second group will be prescribed Normal Saline as a placebo drug. |