| CTRI Number |
CTRI/2020/07/026557 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
13/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of Rasaushadhi and siravedhaprocedure in Headache. |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL TRIAL ON THE EFFICACY OF SIRAVEDHA AND KUMKUMADI GHRITA NASYA ALONG WITH CHANDRAKANTA RASA ORALLY IN ARDHAVABHEDAKA 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 |
Professor Shamsa Fiaz |
| Designation |
Professor and HOD |
| Affiliation |
National institute of ayurveda,jaipur |
| Address |
Room no 309,3rd floor Department of Shalakya tantra national institute of Ayurveda jorawar singh Gate amer road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Shamsa Fiaz |
| Designation |
Professor and HOD |
| Affiliation |
National institute of ayurveda,jaipur |
| Address |
Room no 309,3rd floor Department of Shalakya tantra national institute of Ayurveda jorawar singh Gate amer road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay kumar nayak |
| Designation |
M.S. Scholar |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
Room no 313,3rd floor Department of Shalakya tantra national institute of Ayurveda jorawar singh Gate amer road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9993469939 |
| Fax |
|
| Email |
ajaynayak9939@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director, National Institute of Ayurveda hospital,Amer Road jorawar singh gate jaipur. |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Amer road Jorawar singh gate Jaipur |
| Address |
National Institute of Ayurveda Amer road Jorawar singh gate Jaipur, 302002 Rajasthan. |
| 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 Ajay kumar nayak |
national institute of ayurveda hospital |
OPD No 11,13,14 shalakya Tantra dept Amer road jorawar singh gate
Jaipur
RAJASTHAN |
9993469939
ajaynayak9939@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: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasya with Kumkumadi Ghrita |
15 patients of Ardhavbhedaka, Migraine will be administered with Kumkumadi Ghrita Nasya at dose of 8-10drops through nasal route for 7 days and repeat again for 7 days with 7 day gape.And Chandrakanta Rasa given orally at dose of 125 mg 1 tab twice a day (250mg/day) with honey for 7 days. |
| Comparator Agent |
Siravedha along with oral drug ( Chandrakanta Rasa ) |
15 patients of Ardhavbhedaka, Migraine will be administered Siravadha, Siravedha will be done on right or left temporal vessel just above the eye brow preferably on affected side of head,for 2 times i.e.once in a week.and Chandrakanta Rasa orally at dose of 125 mg 1tab twice aday (250mg/day)with honey for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate in this trial through written informed consent.
2. Patients between18 to 55 years of age from either sex.
3. Patients presenting with symptoms of Ardhavabhedaka/ Migraine described as per Ayurveda and modern science.
|
|
| ExclusionCriteria |
| Details |
1. Secondary headaches caused by meningitis, tumors, encephalitis, head and neck trauma, trigeminal neuralgia, cervical spondylitis, refractive errors, sinusitis and other disorders of cranium, neck, eyes, ears, nose, sinuses, teeth etc.
2. Patients with complicated Migraine like status migrainosus, hemiplegic migraine and having any chronic debilitating disease with other neurological pathology.
3. Pregnant and lactating women.
4. Patients suffering from any other major systemic disorders e.g. tuberculosis, cancer, heart disease etc.
5. Patients unfit for Siravedha such as patients with hemorrhagic diseases (e.g. hemophilia), anaemia, hypotension, severe allergic diathesis and on anticoagulant treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in clinical manifestation of Ardhawbhedak w.s.r.to migraine |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in parameters of ardhawbhedak w.s.r.to Migraine |
60 days. |
|
|
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)
|
15/07/2020 |
| 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="0"
Months="1"
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)?
|
|
Brief Summary
|
This trial will be done to compare clinical efficacy of
Siravedha and Kumkumadi Ghrit Nasya along with Chandrakant Rasa in
Ardhawbhedaka wsr to Migraine. This is an interventional, Open clinical trial.
The sample size is 30 with 2 groups, each group having a sample size of 15
patients. In group A Kumkumadi Ghrita Nasya and chandrakant Rasa will be
given. 1 Tablets of 125 mg twice a day after food (250 mg/day) with
water for 7 days and 8-10 drop of Nasya for 7 day and again for 7 days with 7
days gape, should be given. Duration of trial is 21 days. In group
B Siravedha done and
chandrakant Rasa will be given. 1 Tablets of 125 mg of Chandrakant Rasa
given orally twice a day after food (250mg/day) with water for 7 days and
Siravedha done once a week for two sittings. Duration of trial is 14 days. The
assessment of the clinical response in the total number of patients will be
made on subjective and objective parameters. Objective parameters
include Laboratory Investigations:- CBC, RBS, ESR, LFT ,RFT , Fundus
examination, Vision test by snellens chart and refraction, IOP, CT, BT, HIV,
HbsAg, X Ray PNS. Duration of Study will be 60 days (21 days trial+
60 days follow up). Follow up for 2 months at 15 days interval after
completion of treatment. |