| CTRI Number |
CTRI/2024/12/078725 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Management of Allergic Rhinitis with the help of Shatyadi churna internally and Karpasasthyadi taila Nasya |
|
Scientific Title of Study
|
A clinical study to Evaluate the Efficacy of Shatyadi Churna orally and Karpasasthyadi Taila nasya in the management of vataja pratishyaya wsr to Allergic Rhinitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KENAM SUSHMA |
| Designation |
MS SCHOLAR |
| Affiliation |
DR BRKR GOVT.AYURVEDIC MEDICAL COLLEGE AND HOSPITAL ERRAGADDA HYDERABAD TELANGANA |
| Address |
Room no 9 Shalakya department Dr BRKR govt Ayurvedic college and Hospital Erragadda Hyderabad
Room no 11 Shalakya department Dr BRKR govt Ayurvedic college and hospital Erragadda Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
7032174459 |
| Fax |
|
| Email |
kenamsushma97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR L ANITHA |
| Designation |
MD (AYU) PROFESSOR DEPARTMENT OF SHALAKYA TANTRA |
| Affiliation |
DR BRKR GOVT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL ERRAGADDA HYDERABAD TELANGANA |
| Address |
Room no 9 Dr BRKR govt Ayurvedic college and Hospital Erragadda Hyderabad Telangana
Hyderabad
TELANGANA
500018
India |
| Phone |
9866985751 |
| Fax |
|
| Email |
anitalomite@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR L ANITHA |
| Designation |
MD (AYU) PROFESSOR DEPARTMENT OF SHALAKYA TANTRA |
| Affiliation |
DR BRKR GOVT.AYURVEDIC MEDICAL COLLEGE AND HOSPITAL ERRAGADDA HYDERABAD TELANGANA |
| Address |
Room no9 Dr BRKR govt ayurvedic college and Hospital Erragadda Hyderabad Telangana
Hyderabad
TELANGANA
500018
India |
| Phone |
9866985751 |
| Fax |
|
| Email |
anitalomite@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR Brkr Ayurvedic College and Hospital Erragadda Hyderabad TELANGANA |
|
|
Primary Sponsor
|
| Name |
DRBRKR GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
Room no 9 Shalakya department Dr Brkr govt ayurvedic college and hospital Erragadda Hyderabad |
| Type of Sponsor |
Government 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 |
| KENAM SUSHMA |
DR BRKR GOVT.AYURVEDIC MEDICAL COLLEGE AND HOSPITAL ERRAGADDA HYDERABAD TELANGANA |
Room no 9 Shalakya Department
Hyderabad
TELANGANA |
07032174459
kenamsushma97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF DR BRKRGOVERNMENT AYURVEDIC COLLEGE, HYDERABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: VATAJAPRATISYAYAH, (2) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: VATAJAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHATYADI CHURNA, Reference: BASAVARAJEEYAM, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -GRITA AND GUDA), Additional Information: -GRITA DOUBLE THE QUANTITY OF CHURNA
GUDA EQUAL QUANTITY OF CHURNA | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: ASTANGA HRIDAYA, Procedure details: ABYANGA FOLLOWED BYSWEDANA DONE OVER FACE.THEN KARPASASTHYADI TAILA 6 DROPS INSTILLED IN TO EACH NOSTRIL.
DURATION 3CYCLES WITH A GAP OF 7 DAYS EACH. )
(1) Medicine Name: KARPASASTHYADI THAILA, Reference: SAHASRAYOGAM, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)cases presenting with the Classical Features of Vataja pratishaya
a) Kshavadhu
b) Anaddhapihita Nasa
c)Tanusrava pravarthini
d)Galatalu osta shoshacha
e) Swarabhedha
f) Shirashoola
2)Patients who are indicated for Nasya Karma.
3)Patients willing to give written consent.
|
|
| ExclusionCriteria |
| Details |
Patients below 18 years and above 60years of either gender.
Patient who need surgical and other intervention (Polyp, Rhinitis Sicca and pan simasitis.)
Patient suffering from systemic disorders like Diabetes, Hypertension, Tuberculosis,cardiovascular diseases, thyroid disorders
Pregnant and Lactating women
Patients suffering from Bronchial asthma, skin allergies.
Patients with history of congenital abnormalities of nose and having history of trauma.
Patient contraindicated for Narxya karma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in classical symtoms of allergic rhinitis |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life |
6 weeks |
|
|
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 1 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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="5"
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
|
This is a Randomized clinical trail to evaluate the efficacy of shatyadi churna orally and karpasatyadi taila nasya in the management of Vataja Pratishaya w.s.r to Allergic rhinitis in patients who are clinically diagnosed and confirmed cases of Allergic rhinitis enlisted in inclusion criteria will be in single group of total 30 patients. They will be given shatyadi churna orally 4gms TID with Anupana Ghrita(Double quantity of churna) and Guda(Equal quantity to churna ) for 45 days They will be given Nasya with karpasatyadi taila nasya 6 Drops in each Nostril (marsha nasya) 3 cycles with a gap of 7 days each. Follow up: after 21 days Total duration : 45 days |