| CTRI Number |
CTRI/2020/11/028981 [Registered on: 09/11/2020] Trial Registered Prospectively |
| Last Modified On: |
06/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“Frontal headache management by the use of shadbindu tail administration through nostrils and applying krishnadi lepa in forehead†|
|
Scientific Title of Study
|
“Comparative study to evaluate the therapeutic effect of shadbindu tail nasya with and without krishnaadi lepa in kaphaj shirorog†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaya Singh |
| Designation |
PG SCHOLAR |
| Affiliation |
Patanjali Bhartiya ayurvigyan evam anusandhan sansthan |
| Address |
department of Shalakya Tantra Patanjali Ayurved hospital,phase 1 bahadarabad Haridwar Uttarakhand
Shalakya department Patanjali Ayurved hospital phase 1 bahadarabad Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9713537686 |
| Fax |
01334244805 |
| Email |
drjayasingh92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dayashankar Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya ayurvigyan evam anusandhan sansthan |
| Address |
vaanprastha ashram patanjali yogpeeth phase 2
Shalakya department Patanjali Ayurved hospital phase 1 bahadarabad Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8194028515 |
| Fax |
01334244805 |
| Email |
dayaayush@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dayashankar Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya ayurvigyan evam anusandhan sansthan |
| Address |
vaanprastha ashram patanjali yogpeeth phase 2
Shalakya department Patanjali Ayurved hospital phase 1 bahadarabad Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8194028515 |
| Fax |
01334244805 |
| Email |
dayaayush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurveda College |
| Address |
Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jaya Singh |
Patanjali Ayurved hospital Haridwar |
department of Shalakya Tantra patanjali ayurved hospital
Hardwar
UTTARANCHAL |
9713537686
01334244805
drjayasingh92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Ayurved college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R51||Headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Shadbindu tail nasyam and krishnaadi lepa both will be done once in a day for 7 days |
Nasyam will be done once in a day for 7 day and lepa will be applied on forehead for 7 days |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical symptoms of Kaphajshrorog
Patients Yogya for Nasya Karma and lepa karma.
|
|
| ExclusionCriteria |
| Details |
Patients less than 8 and above 50 years.
Patient suffering from any systemic diseases and receiving medication.
Patients who are contraindicated for Nasya Karma and lepa karma.
Patients suffering from any other forms of headaches apart from Kaphajshirorog.
• Headache secondary to meningitis, tumor, encephalitis, spondylosis or any other intracranial lesions and refractive errors etc.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameter Shirashoola
Shirogaurava
Staimitya
Shitata
Siranishpandata
Alasyam
Aruchi
Tandra
Shunakshikutatva
Karnakandu
Chhardi
Objective parameter
X-ray,PNS
|
before intervention of shadbindu tail nasya and krishnaadi lepa
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Parameter Shirashoola
Shirogaurava
Staimitya
Shitata
Siranishpandata
Alasyam
Aruchi
Tandra
Shunakshikutatva
Karnakandu
Chhardi
Objective parameter
X-ray,PNS
|
after intervention of shadbindu tail nasya and krishnaadi lepa |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/11/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is an open label randomized clinical trial to evaluate the efficacy of shadbindu tail nasya with and without krishnaadi lep in kaphaj shirorog.in this trial patients with classical symptoms of kaphaj shirorog will be selected from IPD and OPD from patanjali ayurveda hospital Haridwar, in which the intervention in two groups (35 patients each) will be done. First group will receive shadbindu tail nasya and second group will receive shadbindu tail nasya with krishnaadi lepa for 7 days each. Assessment will be done on the basis of various parameters as before and after treatment is done. |