| CTRI Number |
CTRI/2025/10/096466 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda treatment for management of Headache |
|
Scientific Title of Study
|
A Study on the Efficacy of Lepa and Pratimarsha Nasya in Vataja Shiroroga with special reference to Yukti Pramana |
| 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 Pooja bulla |
| Designation |
PG Scholar Samhita siddhanta |
| Affiliation |
Raja Rajeswari Ayurvedic Medical Collage Hospital and PG Centre Humnabad |
| Address |
Room No.03, Department of Samhita Siddhanta ,Raja Rajeswari Ayurvedic Medical Collage Hospital and PG Centre Sindenkera cross Humnabad, Karnataka, 585330
Room No.03, Department of Samhita Siddhanta ,Raja Rajeswari Ayurvedic Medical Collage Hospital and PG Centre Sindenkera cross Humnabad, Karnataka, 585330
Bidar
KARNATAKA
585330
India |
| Phone |
6363953609 |
| Fax |
|
| Email |
poojabulla03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avula Srinivas |
| Designation |
Professor and guide |
| Affiliation |
Raja Rajeswari ayurvedic medical collage hospital and PG Centre Humnabad |
| Address |
Room No.03, Department of Samhita Siddhanta ,Raja Rajeswari Ayurvedic Medical Collage Hospital and PG Centre Sindenkera cross Humnabad, Karnataka, 585330
Room No.03, Department of Samhita Siddhanta ,Raja Rajeswari Ayurvedic Medical Collage Hospital and PG Centre Sindenkera cross Humnabad, Karnataka, 585330
Bidar
KARNATAKA
585330
India |
| Phone |
07829413251 |
| Fax |
|
| Email |
srinivasonu16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja bulla |
| Designation |
PG Scholar Samhita siddhanta |
| Affiliation |
Raja Rajeswari Ayurvedic Medical Collage Hospital and PG Centre Humnabad |
| Address |
Room No.03, Department of Samhita Siddhanta ,Raja Rajeswari Ayurvedic Medical Collage Hospital and PG Centre Sindenkera cross Humnabad, Karnataka, 585330
Room No.03, Department of Samhita Siddhanta ,Raja Rajeswari Ayurvedic Medical Collage Hospital and PG Centre Sindenkera cross Humnabad, Karnataka, 585330
Bidar
KARNATAKA
585330
India |
| Phone |
06363953609 |
| Fax |
|
| Email |
poojabulla03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Ayurvedic Medical collage Hospital and PG Centre Sindenkera cross Humnabad 585330 |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Bulla |
| Address |
Rajarajeswari Ayurvedic Medical collage Hospital and PG Centre Sindenkera cross Humnabad 585330 |
| 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 Pooja Bulla |
Raja Rajeswari Ayurvedic Medical Collage And Hospital |
Room No.03, Department of Samhita Siddhanta ,Raja Rajeswari Ayurvedic Medical Collage Hospital and PG Centre Sindenkera cross Humnabad, Karnataka, 585330
Bidar
KARNATAKA |
06363953609
poojabulla03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Rajarajeswari Ayurvedic Medical College Humnabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G968||Other specified disorders of central nervous system. Ayurveda Condition: VATAJA-SIROROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Sushruta Samhita, Procedure details: Traditional method of preparation is used to prepare Go-ghrita and 2 drops are administered into each nostril in the morning hours)
(1) Medicine Name: Go Ghrta, Reference: Sushruta Samhita, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Muchakunda puspa, Reference: Sharangadhara Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Muchakunda puspa churna given Bhavana with kanji and processed in eranda taila |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1 Subjects having the classical Symptoms of Vatajashiraroga like
Todavath Shoola in shankha
Nishi tivra ruja
Bru madhya tapati ativedanam
Lalata tapati ativedanam
2 Subjects aged between 20 to 50 Years of either sex
3 Subjects interested in study will be included
|
|
| ExclusionCriteria |
| Details |
1 Subjects having systemic disorders like uncontrolled DM
hypertension
2 Subjects with tuberculosis HIV and HbsAg infection
3 Headache Secondary to meningitis tumour Spondylosis etc
4 Subjects suffering with
pinasa (chronic sinusitis)
krimija shiro roga
badhirya
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief of Symptoms of Vatajashiroroga
1 Todavath Shoola in shankha
2 Nishi tivra ruja
3 Bru madhya tapati ativedanam 4 Lalata tapati ativedanam
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the effectiveness of Muchkundadi lepa with Go-ghrita pratimarsha nasya in Vatajashiroroga.
2. By applying yukti pramana to above study interpreting the combined effect of both antaha and bahir parimarjana chikitsa in vataja shiroroga.
|
7 days |
| NIL |
NIL |
|
|
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)
|
04/11/2025 |
| 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="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
|
The study is a Open label Comparative Clinical trial to evaluate the effectiveness of Muchakunda puspa lepa and Gogrutha Pratimarsha Nasya With special reference to Yukti pramana. total of 30 subjects fulfilling the inclusion criteria
Study group includes 30 subjects Qualifying the Inclusion Criteria of the current study with Muchakunda puspa lepa and Gogrutha Pratimarsha Nasya With special reference to Yukti pramana 7 days (From Day 1 Day 7 of the trial period). The Primary Outcome measure will be 1 Todavath Shoola in shankha 2 Nishi tivra ruja 3 Bru madhya tapati ativedanam 4 Lalata tapati ativedanam
Time Point : After completion Lepa and Nasya on 7th day |