| CTRI Number |
CTRI/2024/03/063907 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“TO STUDY THE EFFECT OF SHADBINDU TAIL NASYA AND SARIVADI
LEPA IN ARDHAVABHEDAKA WITH SPECIAL REFERENCE TO MIGRAINE†|
|
Scientific Title of Study
|
“RANDOMIZED CONTROLLED CLINICAL TRIAL OF SHADBINDU TAIL NASYA AND SARIVADI
LEPA IN ARDHAVABHEDAKA WITH SPECIAL REFERENCE TO MIGRAINE†|
| 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 Omkar Ramratan Malpani |
| Designation |
PG Scholar |
| Affiliation |
PMTs Ayurved College Shevgaon |
| Address |
OPD NO. 108, PANCHAKARMA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAY
PMTs Ayurveda College,Shevgaon
Akhegaon road, tal. Shevgaon,
Dist. Ahmednagar
Maharashtra
414502
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
|
| Fax |
|
| Email |
omkarmalpani07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep T Shinde |
| Designation |
Professor and HOD |
| Affiliation |
PMTs Ayurveda College,Shevgaon |
| Address |
OPD NO. 108 PANCHAKARMA DEPARTMENT, SHRI EKNATH AYURVED RUGNALAY
PMTs Ayurveda College,Shevgaon
Akhegaon road, tal. Shevgaon,
Dist. Ahmednagar
Maharashtra
414502
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9405766631 |
| Fax |
|
| Email |
vd.sandeepshinde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep T Shinde |
| Designation |
Professor and HOD |
| Affiliation |
PMTs Ayurveda College,Shevgaon |
| Address |
OPD NO. 108 PANCHAKARMA DEPARTMENT SHRI EKNATH AYURVED RUGNALAY
PMTs Ayurveda College,Shevgaon
Akhegaon road, tal. Shevgaon,
Dist. Ahmednagar
Maharashtra
414502
MAHARASHTRA
414502
India |
| Phone |
9405766631 |
| Fax |
|
| Email |
vd.sandeepshinde@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMTs AYurveda College Shevgaon
414502 |
|
|
Primary Sponsor
|
| Name |
PMTs Ayurveda College Shevgaon |
| Address |
Shevgaon, Tal. Shevgaon
Dist. Ahmednagar
Maharashtra
414502 |
| Type of Sponsor |
Private 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 Omkar Malpani |
PMTs Ayurveda College Shevgaon |
Panchakarma Dept. OPD NO 108
Shri Eknath Rugnalay AND PMTS AYURVED COLLEGE SHEVGAON
Akhegaon Road, Shevgaon
414502
Ahmadnagar
MAHARASHTRA |
9922963654
omkarmalpani07@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:G431||Migraine with aura. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Vaidya Yadavji Trikamji ,Sushruta samhita, with Nibandha Sangraha commentary of Dalhana & nyayaChandrika of Sri Gayadasa , published by Chaukhambha orientalia, 2007 edition, uttarsthana 26/34 P no. 360 , Procedure details: Bharad churna of all 4 drugs will be taken in khalvayantra. Fine powder will be made
and kanji bhavana will be given and a readymade kanji will be taken.
Application -
Purva karma: The required quantity of lepa powder in enough quantity of GOGHRUT,
TILTAIL is taken and mixed properly.
Pradhan karma: After cleaning face apply a paste of powder on forehead one time in
morning for 15 minutes.
Paschat karma: After drying of powder remove the paste with water. Repeat this
daily up to)
(1) Medicine Name: Shadabindu Tail, Reference: Lepa will be applied daily for 7 days. follow up will be on 0th, 7th, 14th and 30th day, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shadabindu Tail, Reference: Gangasahaya Pande. Gadanigraha with Vidyotini Hindi commentary by Sri Indudeva Tripathi, edition 2nd Part-II (Kayachikitsa Khanda) Nasarogadhikara, Varanasi; Chaukhamba Sanskrit sansthana: 1991.p.191. , Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -- |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
k/c/o Migraine/ Ardhavabhedakah
Patients fulfilling diagnostic criteria of Ardhavabhedakah / Migraine will be selected randomly irrespective of sex, religion, occupation |
|
| ExclusionCriteria |
| Details |
Referred pain in one half of the head due to disordr of eye, ear, nose, throat, teeth.
h/o secondary headache/ IC host / malignancy / first time severe headache
Patients not fulfilling diagnostic criteria
Patient who was on any other medication which may interfere with trial treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of Sarivadi lepa and shadbindu tail nasya in
ardhavabhedaka with special reference to migraine.
Is there any reduction in symptoms or frequency of symptoms of migraine will be assesed after month |
7 days treatment with 4 follow ups. 0,7th,14th and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review the details of ARDHAVABHEDAKA in ayurveda and modern.
To study LEPA Kalpana and Nasya kalpana in detail.
To compare efficacy of Shadbindu tail and sarivadi lepa with shadbindu tail alone.
To observe any adverse drug effect |
7 days treatment with follow up on baseline 0th, 7th, 14th, 30th day. |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="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
|
Migraine has become a global issue with global prevalence of 14.7 %. In Asian countries including India average prevalence of migraine is 14 – 20 %. In females’ prevalence rate is goes beyond 25%. Chronic migraine affects approximately 2% of the world population. Migraine and chronic headache are found to be the second most frequently identified cause of short-term absence for non-manual employees, and amongst the five leading causes of emergency department visits. Migraine remains undiagnosed and undertreated in at least 50% of patients, and less than 50% of migraine patients consult a physician . Migraine ranks sixth highest cause of the disease burden as per the years lived with disability (YLD) criteria. In modern science there are different modalities present for the treatment of migraine, but they aren’t satisfactory as they don’t relive disease completely & providestemporary relief also chances of recurrence are more hampering patient physically, mentally & economically also. Ayurveda shows a promising way for the treatment of migraine (ardhavabhedaka). There are many shamana chikitsa & shodhana chikitsa are described in ayurveda texts. In Ayurveda Nasya therapy is considered as one of the most promising treatment for all the urdhwajatrugat vikaras. Nasya karma involve administration of herbal oil/drugs/liquids into the nostrils which removes the blockages of the nasal pathways, reduces feeling of heaviness in head region & relief mental stress. These effect of Nasya gives significant relief in diseases associated with nose & head region such as; migraine (Ardhavbhedaka). Shadbindu tail is proven drug in Ardhavabhedaka with efficacy of approximately 60%. Shadbindu tail is mentioned in Bhavaprakash madhyam khanda 2 shirorogadhikar and gadanigraha part 2 tail prakaran13. SARIVADI LEPA is mentioned in Sushrut Samhita Uttarsthan 26/34. It is also mentioned in SHARANGDHAR SAMHITA 3/11/23 and YOGRATNAKAR shirorog chikitsa with some modification in drugs. Sarivadi lepa is selected as add on effect on shadbindu tail to increase its efficacy. Lepa is easy for application and all drugs in this lepa are easily available and very cost effective. Till today no research has been carried out on SARIVADI LEPA. |