| CTRI Number |
CTRI/2025/07/090405 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Randomised controlled clinical trial to determine the efficacy of saindhava sanyukta dashmool ghrita nasya in management of ardhavabhedaka with special reference to common migraine. |
|
Scientific Title of Study
|
Randomised controlled clinical trial to determine the efficacy of Saindhava Sanyukta Dashmool Ghrita Nasya in management of Ardhavabhedaka with special reference to Common 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 |
Kalyani Sanjay Takarkhede |
| Designation |
Pg Scholar |
| Affiliation |
SSTAC Sangamner |
| Address |
Dept Of Shalakyatantra SSTAC Sangamner
Ahmadnagar
MAHARASHTRA
422605
India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7387787574 |
| Fax |
|
| Email |
kalyanitakarkhede09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Deshmukh |
| Designation |
HOD of Dept of Sahalakyatantra |
| Affiliation |
SSTAC Sangamner |
| Address |
Dept of Shalakyatantra SSTAC Sangamner
Ahmadnagar
MAHARASHTRA
422605
India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9822262627 |
| Fax |
|
| Email |
ranwaraanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Deshmukh |
| Designation |
HOD Of Dept of Shalakyatantra |
| Affiliation |
SSTAC Sangamner |
| Address |
Dept of Shalakyatantra SSTAC Sangamner
Ahmadnagar
MAHARASHTRA
422605
India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9822262627 |
| Fax |
|
| Email |
ranwaraanil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Shalakyatantra SSTAC Sangamner
Ahmadnagar (MH)
422605
India |
|
|
Primary Sponsor
|
| Name |
Kalyani Sanjay Takarkhede |
| Address |
Dept of Shalakyatantra SSTAC Sangamner
Ahmadnagar(MH)
422605
India |
| Type of Sponsor |
Other [Own Research Study] |
|
|
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 |
| Kalyani Sanjay Takarkhede |
Sangam Sevabhavi Trust Ayurved Mahavidyala , Sangamner |
OPD Division 1st floor,
Room no -3
Shalakyatantra OPD
Ahmadnagar
MAHARASHTRA |
7387787574
kalyanitakarkhede09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee SSTAC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saindhava Sanyukta Dashmool Ghrita Nasya, Reference: Chakradatta 60/44, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: -, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Go Ghrita Nasya, Reference: Bhaishajya Ratnavali 65/34, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: -, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients whose informed written consent has been taken.
2. Patients between age group 18 to 60 years (Male and Female).
3. Patients fulfilling the diagnostic symptoms such as unilateral headache, nausea ,vomiting , vertigo of Ardhavbhedaka will be selected randomly irrespective of age, sex, religion and occupation.
4. Patients fit for Nasya karma. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from Shiroroga like Sooryavarta.
2.Systemic disorders such as DM, HTN, etc which will affect or interfere course of treatment.
3.Patients contraindicate for Nasya karma. 4.Secondary headache caused due to meningitis, encephalitis, cervical spondylosis.
5.Referred pain due to diseases of eye, ear, nose, teeth etc.
6.Patients with complicated migraine that is complications like loss of hearing, loss of vision. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Migraine |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Symptoms of Migraine. |
21 Days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
17/07/2025 |
| 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
|
According to Acharyas there are 11 types of Shiroroga. Ardhava bhedaka is among 11 types of Shiroroga. Ardhavabhedaka word has components viz. Ardha and Avabhedaka. Ardha which means half side, Ava word suggests about bad prognosis and Bhedaka which means bursting, breaking, perforating type of pain. Acharya Chakrapani mentioned ‘Ardha Mastaka Vedana’ for Ardhavabhedaka.Ardhavabhedaka devleops at interval of fortnight i.e 15 days or 10 days or a month.Ardhavabhedaka has severe complications such as it can produce deafness, blindness or it can destroy sense organs also.According to Ayurveda common migraine is found to identical in nature to Ardhavabhedaka characterized by half side pain in head (i.e Vedana in half portion of head is called as Ardhavabhedaka ). There are several types of migraines. The most common migraine categories are migraine without aura is called as common migraine and migraine with aura is called as classical migraine.Common migraine, is the more frequent form of migraine. Symptoms include headache pain that occurs without warning and is usually felt on one side of the head, along with nausea, Vomiting, vertigo , confusion, blurred vision, mood changes, fatigue.According to Acharyas Ardhavabhedaka is best treated with Ghrita, Taila and Majja, Shiro Virechana, Kaya Virechana, Nadisveda, Niruha and Anuvasana, Basti, Upanaha and Shiro-basti Ayurveda has the Nasya therapy as master key for Shiroroga, method to rejuvenate the body and mind and to alleviate pain and stress. Medicines which is administered through the nasal route is directly deliver to the brain and expel the vitiated Doshas. Bhaishajyaratnavali mentioned Goghrita use for Nasya Karma in Ardhavbhedaka.Here in this study the trial drugs selected Saindhava Sanyuktaa Dashmool Ghrita Nasyafrom Chakradatta also for control group Go Ghrita Nasya is taken mentioned in Bhaishajyaratnavali. Need for Study.The present day diet, life style, irregular diet habits, fermented, pickled foods, baked items, chocolates, dairy products and changes in sleep pattern like awakening in night times due to night duties and sleeping in day time are predisposing factors of Ardhavabhedaka. According to data from the World Health Organization, it is the 3rdmost prevalent medical condition in the world, affecting 14.7% of the population annually in India.It is the second most common cause of headache, it afflicts approximately 15% of women and 6% of men worldwide.Its prevalence is the highest during young and middle adulthood and peaks between the age of 30 and 39.Ardhavbhedaka is Vata predominate Vyadi. All the drug inDashamoola has Ushna Virya, Katu Rasa and Tikta Rasa. Most of the contents in Dashamoola Kwatha Yoga is having Shothahara, Vedanasthapana, Deepana, Pachana and Tridoshashamaka Karma Deepana-Pachana Karma, which causes Amapachana and thus provides proper metabolism and ultimately balances the Agni.Dashamoola had anti-inflammatory, analgesic and anti-platelet effects. Ghrita is Ojovardhaka, Agni Deepana and Dhatuposhaka. By virtue of its Sanskaranuvartana property, it attains the properties of ingredients without losing its own. Due to lipophilic action of ghritaabsorption , digestion and delivery to target organ made easy when any drug is processed with ghrita. Antioxidant effect of go ghrita is due to Vitamin A and Vitamin E content .According to Bhaishajyaratnavali in Ardhavbhedak Goghrita Nasya is used. Acharya Chakradatta explained Dashamool kwath with ghrita and Saindhava nasya for Ardhavabhedaka but daily preparation of fresh kwath with ghirta and Saindhava and it’s nasya is practically difficult as shelf life of Kwatha is also less than ghrita hence in present study decided to prepare Saindhava Sanyukta Dashmool ghirta according to classical method mentioned in sharangadhara Samhita and with help of some review from previous Ayurvedic Research. Also Saindhav is used as Nasya Dravya by Acharya Charaka Saindhava is Vrushya, Hridya and keeps Tridoshas in normal state. It is Laghu, Anushna, good for vision, and Strotoshodhaka Property. In modern medicine drugs like Acetaminophen, Sumatriptan has complications like drowsiness, insomnia, depression, extra pyramidal activities; constriction of blood vessels are predisposing the cardiac problem. There is need of studies on the prevalence of Ardhavvabhedaka in our country and there is huge scope for devlopment in context of Ayurvedic herbal formulations .So, it is very necessary to do some effective work on this topic . Through the review of previous Ayurvedic research , the study has been done on comparative Evaluation of Dashmool Saindhava sarpi as nasya versus Oral administration in management of Ardhavabhedaka (migraine) taking this into account this clinical trial differs from previous study as this clinical trial includes Go ghirta nasya as control drug and Saindhava Sanyukta Dashmool ghrita nasya as trail drug. The purpose of the clinical trial is primarily to eshtablish the efficacy of these nasya Drug as it is cost effective , easily available. Hence study has been planned as Randomised controlled Clinical trial to determine the efficacy of Saindhava Sanyukta Dashmool Ghrita Nasya in management of Ardhavabhedaka with special reference to Common Migraine. |