| CTRI Number |
CTRI/2024/05/067272 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Agnikarma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical trial of efficacy of Agnikarma with
and without Laghusutashekhra rasa in the management of
Ardhavabhedaka w.s.r. to Migraine without aura |
|
Scientific Title of Study
|
Randomized comparative clinical trial of efficacy of Agnikarma with
and without Laghusutashekhra rasa in the management of
Ardhavabhedaka w.s.r. to Migraine without aura |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shekh Afreen Naaz |
| Designation |
PG scholar |
| Affiliation |
SST Ayurved College, Sangamner |
| Address |
Ssts ayurved college, nashik pune highway, sangamner, Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8208271674 |
| Fax |
|
| Email |
Afreensa95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shekh Afreen Naaz |
| Designation |
PG scholar |
| Affiliation |
SST Ayurved College, Sangamner |
| Address |
Ssts ayurved college, nashik pune highway, sangamner, Dist Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8208271674 |
| Fax |
|
| Email |
Afreensa95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bargal Rohan Shivaji |
| Designation |
Assi. Professor |
| Affiliation |
SSTs Ayurved College, Sangamner |
| Address |
Ssts ayurved college, nashik pune highway, sangamner, Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9096302784 |
| Fax |
|
| Email |
rohanbargal3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ssts ayurved college, nashik pune highway, sangamner, Dist Ahmadnagar 422605 |
|
|
Primary Sponsor
|
| Name |
Shekh Afreen Naaz |
| Address |
Ssts ayurved college, nashik pune highway, sangamner, Dist Ahmadnagar 422605 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shekh Afreen Naaz |
Sangam sevabhavi trusts ayurved college |
OPD no 05, department of Shalakyatantra, Nashik pune highway, sangamner
Ahmadnagar
MAHARASHTRA |
8208271674
Afreensa95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangam sevabhavi trusts ayurved college, sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G09||Sequelae of inflammatory diseasesof central nervous system. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Ashtang Hrudaya Sutrasthana 30/40-45, Procedure details: Procedure details
Avadhi - Once in a week (Saptah)/ after the healing of the wound.
Asana - Position - Lateral supine with affected side facing upward.
Pradhana karma - Assess the most tender point on affected Shankh-Bhru-Lalat Pradesh (Temporal region of face). Clean the site with koshna jala. Karma Vidhana - Heat the Shalaka on high flame till red hot. (Approx. time 4 -5 minutes depending upon temperature of the flame), before that brand a mark on prior assessed most tender point accordi)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Ashtang Hrudaya Sutrasthana 30/40-45, Procedure details: Procedure details
Avadhi - Once in a week (Saptah)/ after the healing of the wound.
Asana - Position - Lateral supine with affected side facing upward.
Pradhana karma - Assess the most tender point on affected Shankh-Bhru-Lalat Pradesh (Temporal region of face). Clean the site with koshna jala. Karma Vidhana - Heat the Shalaka on high flame till red hot. (Approx. time 4 -5 minutes depending upon temperature of the flame), before that brand a mark on prior assessed most tender point accordi)
(1) Medicine Name: Laghusutashekhara rasa, Reference: Ayurvediya Aushadha gunadharma Gangadharshastri Gune page no. 447,, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age group 18 to 60 years.
2. Patient’s fulfilling the diagnostic symptoms of Ardhavbhedaka like - recurrent attacks of headache(shirovedana), mostlyunilateral in site, variable in intensity, frequency and duration with or without nausea (hrullasa), vomiting (chardi), vertigo (bhrama) will be selected
randomly irrespective of age, sex, religion and occupation.
3. Patients fit for Agnikarma. |
|
| ExclusionCriteria |
| Details |
1. Any other known systemic disorders which will affect or
interfere course of treatment e.g., Hypertension, DM
2. Patient’s not fit for Agnikarma19
.
3. Secondary headache caused due to meningitis, encephalitis,
cervical spondylosis.
4. Referred pain due to diseases of eye, ear, nose, teeth etc.
5. Patients with complicated migraine that is complications
like loss of hearing, loss of vision. |
|
|
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 |
| Reduction in classical sign & symptoms of Ardhavbhedaka |
7th, 14th, 21st and 28 th day and post treatment 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the efficacy of Agnikarma and Laghusutashekhara
rasa along with agnikarma in the management of Ardhavabhedaka
w.s.r. to Migraine without aura.
2. To evaluate combined efficacy of Laghusutashekhara rasa along
with agnikarma in the management of Ardhavabhedaka w.s.r. to
Migraine without aura. |
7th, 14th, 21st and 28 th day and post treatment 15th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
24/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim this clinical trial is to compare the efficacy of Agnikarma and Laghusutashekhara rasa along with agnikarma in the management of Ardhavbhedaka w.s.r. migraine without aura. The clinical trial will be conducted on total 80 patients of Ardhavbhedaka fulfilling inclusion criteria. There will be follow up on 7th, 14th, 21st & 28th day. There will be post treatment follow up after 15 days. The assessment will be carried on the basis of subjective & objective parameters. After that statistical analysis will be carried out and conclusion will be drawn. |