| CTRI Number |
CTRI/2022/05/042560 [Registered on: 13/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Panchkarma therapy i.e.nasya karma and oral drug] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nasya treatment in migrain |
|
Scientific Title of Study
|
A Comparative study on the effect of balahatadi tail nasya with and without priyala kharjooradi yog(kalpit) in ardhaavbhedhaka W.S.R to migraine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev sood |
| Designation |
Principal, HOD of Panchkarma department of Dayanand ayurvedic College jalandhar punjab |
| Affiliation |
Dayanand Ayurveda College Jalandhar (Punjab) |
| Address |
Deptt.of panchkarma of Dayanand ayurvedic College jalandhar punjab
Pincode 144003
Jalandhar
PUNJAB
144003
India |
| Phone |
981400412 |
| Fax |
|
| Email |
drsanjeevsood@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev sood |
| Designation |
HOD of Panchkarma deptt.and principal of Dayanand ayurvedic College jalandhar punjab |
| Affiliation |
Dayanand Ayurveda college Jalandhar affiliated to Guru Ravidas University Hoshiarpur Punjab |
| Address |
Deptt.of panchkarma of Dayanand ayurvedic College jalandhar punjab
Pincode 144003
Jalandhar
PUNJAB
144003
India |
| Phone |
9814004142 |
| Fax |
|
| Email |
drsanjeevsood@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi saroch |
| Designation |
M.D. Student |
| Affiliation |
Dayanand Ayurveda College,Jalandhar |
| Address |
Room no 4, Department of Panchkarma of Dayanand ayurvedic College Jalandhar
Jalandhar
PUNJAB
144003
India |
| Phone |
8894483934 |
| Fax |
|
| Email |
Sarochsakshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand ayurvedic pharmacy Jalandhar punjab |
|
|
Primary Sponsor
|
| Name |
Self Dr Sakshi Saroch |
| Address |
Panchkarma department Dayanand Ayurvedic college and hospital Jalandhar on Mahatma hansraj road near GT road
Pincode 144003 |
| Type of Sponsor |
Other [M.D. Scholar Dr.Sakshi Saroch is herself will be the Primary sponsor] |
|
|
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 Sakshi saroch |
Dayanand ayurvedic college Jalandhar Punjab |
Room no.4 Department of Panchkarma
Jalandhar
PUNJAB |
8894483934
sarochsakshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Priyala kharjooradi yog, Reference: Kalpit, Route: Oral, Dosage Form: Modaka , Dose: 8(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -lukewarm milk), Additional Information: -This yog will be given along with nasya for 21 days. | | 2 | Comparator Arm | Procedure | - | Nasyam | (Procedure Reference: Sahasrayogam, Procedure details: 8 drops of balahatadi tail per nostril will be given for 21 days.)
(1) Medicine Name: Balahatadi tailum, Reference: Sahasrayogam, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 21 Days |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(1)Patient wiling for study.
(2)Patient with classical lakshan of Ardhavbhedak/migrain.
(3)Patient of age between 16-60yrs irrespective of sex,religion and occupation will be selected fir study.
(4)Patient fit for Nasya karma
|
|
| ExclusionCriteria |
| Details |
(1)Patient not willing for study.
(2)Patient suffering from any other forms of headache apart from Ardhavbhedak.
(3) Headaches secondary to medical conditions like Meningitis,Tumor, encephalitis,spondylosis or any other intracranial lesions and refractive errors etc.
(4)Patients with complications of Migrain e.g.status migrainosus,migrain aura triggered seizure,probable migraine etc.
(5)Patients who are contraindicated for Nasya karma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical symptoms will be assessed depending on severity of
1) Headache(half sided pain)
2) Frequency of headache
3) Duration of headache
4) Nausea
5) Vomiting
6) Vertigo
7) Aura
For example, For Duration of headache, scoring will be done like
Nil-0
1-3 hours/day-1
3-6 hours/day-2
6-12 hours/day-3
More than 12 hours/day -4 |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
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)
|
14/05/2022 |
| 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="10"
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
|
This trial will be done to compare the efficacy of Balahatadi tail Nasya and Balahatadi tail Nasya along with priyala kharjooradi yog 8gm(modak) in a single dose with lukewarm milk.The Duration of treatment will be given for 21 days.Total 30 Patients will be taken for the trial divided in two groups having 15 Patients in each group will be taken .Mode of administration of drug will be nasya in which first sthanik abhyangam will be done with tila tailum and sthanik vashpa swedan will be given.Pardhan karma will be Nasya given by Balahatadi tailum and Paschat karma will be done with Haridra Dhoompana and ushana jal kavalgraha |