| CTRI Number |
CTRI/2025/06/088226 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to study the Effect of a nasal drops of desmodium gangeticum plant and topical application of cassia tora in in migraine |
|
Scientific Title of Study
|
Effectiveness of sthira rasa nasya and prapunnada amla kalka lepa in 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 |
JINU JOJAN |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVT AYURVEDA COLLEGE THIRUVANATHAPURAM |
| Address |
room no5,department of shalakyatantra,GAVC Thiruvananthapuram
,KERALA,INDIA
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7025869050 |
| Fax |
|
| Email |
jinujojan46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JEEJA SASI |
| Designation |
ASSOCIATE PROFESSOR,DEPARTMENT OF SHALAKYA TANTRA ,GAVC TVM |
| Affiliation |
GOVT AYURVEDA COLLEGE THIRUVANATHAPURAM |
| Address |
ASSOCIATE PROFESSOR,DEPARTMENT OF SHALAKYA TANTRA ,GAVC TVM
ASSOCIATE PROFESSOR,DEPARTMENT OF SHALAKYA TANTRA ,GAVC TVM
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9446412673 |
| Fax |
|
| Email |
drjeejasasi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JINU JOJAN |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVT AYURVEDA COLLEGE THIRUVANATHAPURAM |
| Address |
room no 5 ,dept of shalakyatantra ,GAVC tvm,695001
room no 5 ,dept of shalakyatantra ,GAVC tvm,695001
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7025869050 |
| Fax |
|
| Email |
jinujojan46@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT AYURVEDA COLLEGE TRIVANDRUM |
|
|
Primary Sponsor
|
| Name |
JINU JOJAN |
| Address |
DEPARTMENT OF SHALAKYATANTRA GAVC TVM,695001,KERALA,INDIA |
| Type of Sponsor |
Other [PRINCIPAL INVESTIGATOR] |
|
|
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 |
| JINU JOJAN |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
ROOM NO 5,department of shalakyatantra,gavc tvm
Thiruvananthapuram
KERALA |
7025869050
jinujojan46@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:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | नस्यम् | (Procedure Reference: ASHTANGA HRDAYA, Procedure details: STHIRA ie Desmodium gangeticum will be taken samoola ie the whole plant cleansed , washed, pounded and filtered and the swarasa will be taken for nasya)
(1) Medicine Name: sthira swarasa, Reference: ashtanga hrdaya, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 3(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: ashtanga hrdaya, Procedure details: The lepa is to be prepared with seeds of prapunnada ie Cassia tora.The seeds will be pounded & mixed with Dhanyamla and formed into a paste for application))
(1) Medicine Name: prapunnada amla k, Reference: ashtanga hrdaya, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 50(g), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients satisfying diagnostic criteria
2. Age: 12-45 years
3. Gender: Irrespective of gender
4. Those who are willing to give consent
|
|
| ExclusionCriteria |
| Details |
1. Those who are already diagnosed of other types of headaches under ICHD 10
2. Pregnant woman and lactating mothers
3. Patients with complicated migraine: status migrainosus, ophthalmic migraine, hemiplegic migraine, retinal migraine, basilar artery migraine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect of sthira rasa nasya and lepa with prapunnada amla kalka in relieving the intensity of pain assessed by VAS scale in participants of age group 12 to 45 years.
|
82 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the effect of sthira rasa nasya & prapunnada amla kalka lepa in reducing duration of pain & frequency of attack & other associated symptoms of migraine in participants of age 12 to 45 yrs |
21 st day 52 nd day 82 nd day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/06/2025 |
| 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)
|
Open to Recruitment |
| 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 can be defined as a type of headache. Triggering factors of migraine includes dietary factors, sleep disturbances and emotional stress. Considering these factors as modifiable agents in the prevention of the disease, the present study is to compare the add on effect of sthira rasa nasya and prapunnada amla kalka lepa in the subjective parameters and quality of life of patients of Migraine. Cases will be diagnosed using the International Headache Society diagnostic criteria for migraine. Initial and final assessment will be conducted on subjective parameters and quality of life on 0th 21 st days and follow up on 52nd and 82nd day respectively using Visual Analogue Scale . Data will be collected and statistically analysed for conclusion.
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