| CTRI Number |
CTRI/2024/07/070740 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Management of Vatika Shirashoola (Tension type headache) |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Effect of Ksheerbala Taila Nasya and Varanadi Ghrita Nasya along with Go- Ghrita Pana in the Management of Vatika Shirashoola/Tension-type Headache |
| 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 Chanchal |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
OPD Room no. 50 Shalakya KNMS Institute for Ayurved Studies and Research Hospital, Shri Krishna Ayush University, Umri road, Sec. 8, Kurukshetra 136118
Kurukshetra HARYANA 136118 India |
| Phone |
7404741210 |
| Fax |
|
| Email |
chanchalchaudhary987@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manoj Kumar |
| Designation |
Associate professor |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room No. 109, PG Dept of Shalakya Tantra Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Umri road, Sec. 8, Kurukshetra 136118
Kurukshetra HARYANA 136118 India |
| Phone |
9996310888 |
| Fax |
|
| Email |
drmanojtanwar23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Chanchal |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
OPD No. 50 Shalakya KNMS Institute for Ayurved Studies and Research Hospital, Shri Krishna Ayush University, Umri road, Sec. 8, Kurukshetra 136118
Kurukshetra HARYANA 136118 India |
| Phone |
7404741210 |
| Fax |
|
| Email |
chanchalchaudhary987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research, Umri road, Sec 8, Kurukshetra
Haryana (136118) India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Sector-8 Umri Road Kurukshetra 136118 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chanchal |
Institute for Ayurved Studies and Research Hospital |
Room No. 50, Shalakya Tantra (ENT OPD) KNMS,, Sector-8 Umri Road Kurukshetra 136118 Kurukshetra HARYANA |
7404741210
chanchalchaudhary987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee on Human Research of ICMR, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G442||Tension-type headache. Ayurveda Condition: VATAJA-SIROROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Sharangdhar Samhita, Procedure details: Marsha Nasya with Varanadi ghrita .
Go-ghrita pana 10 ml at night after meal.
(3 sittings 7 day each with an interval of 7 days in between)) (1) Medicine Name: Varanadi Ghrita, Reference: Ashtang Hridaya, Route: Nasal, Dosage Form: Ghrita, Dose: 2.7(ml), Frequency: od, Duration: 35 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Sharangdhar Samhita, Procedure details: Marsha Nasya with Ksheerbala taila along with Go-ghrita pana 10 ml at night after meal. (3 sittings 7 day each with an interval of 7 days in between)) (1) Medicine Name: Ksheerbala Taila, Reference: Ashtang Hridaya, Route: Nasal, Dosage Form: Taila, Dose: 2.7(ml), Frequency: od, Duration: 35 Days |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age- 16-60 years
2) Patients with sign and symptoms of Vatika Shirashoola (Tension Type Headache) will be selected irrespective of Sex, Religion and Profession.
3) Patients those are fit for Nasya Karma according to Ayurveda text. |
|
| ExclusionCriteria |
| Details |
1) The patient having any systemic illness, like - Diabetes mellitus, Hypertension, Tuberculosis, Anaemia, Hypotension & fever etc.
2) Patients suffering from head injury, and other type of headaches except tension type headache.
3) Patients Contraindicated for Nasya Karma.
4) Pregnant and lactating mothers.
5) Individuals suffering from general debilitating health condition, immunocompromised disease or on immunosuppressive drugs.
6) Patients with alcohol, opioids other drug addiction and using any other systemic drugs which may alter the result of study.
7) Patients not willing to be registered for clinical study. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in the hematological findings i.e. TLC, DLC, ESR and Hb%.
2.Changes in the opthalmological findings.
|
36th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction sign and symptoms of Vaatika Shirashoola.
|
70th day |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
05/08/2024 |
| 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 Yet Recruiting |
| 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
|
Vatika Shirashoola is most frequently seen because of the vata prakopaka nidanas like ucchabhasana, tikshna madyapana, ratri jagarana, vegadharana, langhana, aaghata ,shoka, bhaya, chinta, characterized by pricking pain at shankha pradesha, ghata sambidhyate (cutting type of pain in posterior aspect of neck), tapa (burning sensation and pain in forehead) and ativedana in bhru madhye and lalata,vadhyetae swanataha (noise heard by the patient in both ear),srotro niskrusyatae(loss of hearing power), nishkruhsyete ivaakshini (feeling of eyes extruded outwards),sarva sandhi muchanam(there is giddiness and the joints are severed as it where), sphuratyati sira jalam (excessive throbbing of the vein with pulsation). In Vataja Shiro roga, ratrikala ati vedana is present i. e. pain aggravates severely in night and is relieved by binding and fomentation. Tension Type Headache can be compared with Vatika Shirashoola described in Ayurvedic texts, as psychological factors like excessive weeping, fear, terror have also been attributed in its samprapti. In Ayurveda, the Acharyas have recognized the importance of medicines, especially of the herbal medicines. There is no permanent treatment of tension type headache in modern therapy. Treatment protocol is not fixed as no unique etiology, pathogenesis and diagnosis criteria is known. Hence there is a need to develop safe and permanent treatment for TTH. Drugs having Urdhvajatrurogahara and Vatahara properties are added choice in the management of Vatika Shirashoola. So Vatahara properties of Ksheerbala taila, Varanadi ghrita and Go- Ghrita is the reason behind the selection of drug amongst the medicinal heritage of traditional Indian medicine. This study gives importance to break the Samprapti of the disease through Shamana process. Nasya is considered as the best procedure in all Urdhvajatrugata rogas. Hence in present study, Nasya with Varanadi ghrita and Ksheerbala Taila along with Go-Ghrita pana is considered. |