| CTRI Number |
CTRI/2025/07/091787 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of
Kshavakadi Taila nasya and Brihad dadimashtak churna in allergic rhinitis |
|
Scientific Title of Study
|
Randomized open labeled controlled clinical trial of
Kshavakadi taila nasya and Brihad dadimashatak churna in kaphaj
pratishyaya with special refernce 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 |
Dr Puja Sharadchandra Pandit |
| Designation |
Assistant professor, Dept. of Shalakya tantra |
| Affiliation |
YCAMC And Hospital, Aurangabad, Maharashtra |
| Address |
OPD of Shalakyatantra (ENT),
YCAMC And Hospital, Nipini Bhalgaon, Beed road, Aurangabad, Maharashtra
431007
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
9561710449 |
| Fax |
|
| Email |
poojapandit28913@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisar Ali Khan |
| Designation |
Professor And H.O.D. Dept. of Shalakyatantra |
| Affiliation |
Govt, Ayurvedic College and Hospital Nanded |
| Address |
OPD no. 27, Dept of Shalakyatantra Govt, Ayurvedic College and Hospital, Near S.P office, Vazirabad, Nanded, 431601, Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9325607099 |
| Fax |
|
| Email |
Dr.khan_na@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puja Sharadchandra Pandit |
| Designation |
Assistant professor, Dept. of Shalakya tantra |
| Affiliation |
YCAMC And Hospital, aAurangabad |
| Address |
OPD no.117, Dept. of Shalakya tantra, YCAMC And Hospital,
Nipini Bhalgaon, Beed road, Aurangabad, Maharashtra
431007
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
9561710449 |
| Fax |
|
| Email |
poojapandit28913@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. OF Shalakyatantra, Govt Ayurvedic College And Hospital, Nanded, Maharashtra, India 431601, India |
|
|
Primary Sponsor
|
| Name |
Dr. Puja Sharadchandra Pandit |
| Address |
YCAMC and Hospital, Nipani-Bhalgaon, Chh.Sambhajinagr 431001, Maharashtra |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Puja Sharadchandra Pandit |
Govt. Ayurvedic College and Hospital |
OPD no. 27, Dept. of Shalakya tantra, Near S.P office, Vazirabad, Nanded, Maharashtra, India
Nanded
MAHARASHTRA |
9561710449
gac.nanded@gmail.com |
| Dr Puja Sharadchandra Pandit |
Yashvantrao Chavhan Ayurvedic Medical College and Hospital |
OPD no.117 Of Shalakyatantra (ENT), Deot. of Shalakyatantra Nipani Bhalgaon,Beed road Aurangabad 431001 Maharashtra
Aurangabad
MAHARASHTRA |
02402356565
02402329696
ycamcoffice22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurvedic College and Hospital, Nanded |
Approved |
| Institutional Ethical Committee Yashvantrao Chavan Ayurvedic medical college and Hospital, Chhatrapati Sambhajinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kshavakadi taila, Reference: Ashtang Sangrah uttarsthan Nasarogpratishedha chapter 24, Verse 18,, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -Nasya Dose - 4-8 drops OD for 7 days (2 settings with 7 days interval) Time – at morning(2) Medicine Name: Brihad dadimashatak churna, Reference: Sharangdhar Samhita, Madhyam khanda verse 6/62-64, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jalpana), Additional Information: -Nasya Dose - 4-8 drops OD for 7 days (2 settings with 7 days interval) Time – at morning | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Anu taila, Reference: Ashtang Hridayam Sutrasthan 20/38., Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -4-8 drops OD for 7 days (2 settings with 7 days interval) Time – at morning(2) Medicine Name: Vyoshadi vati, Reference: Ashtang Sangrah Uttarsthan 20/5-6, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jalpana), Additional Information: -4-8 drops OD for 7 days (2 settings with 7 days interval) Time – at morning |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)
Patients selected as per diagnostic criteria who are suffering from Kaphaj Pratishyaya.
2)
Patients who are willing for treatment.
Diagnostic criteria:
1)
Nasasrava -Thin, watery, clear
2)
Kshavathu – frequent sneezing
3)
Shiro -gala-talu kandu
4)
Shirogurutva
5)
Recurrent attacks of cold with exposure to allergens
|
|
| ExclusionCriteria |
| Details |
C) Exclusion criteria:
Local:
1)
Patients suffering from nasal benign and malignant tumor.
2)
Patients suffering from epistaxis.
3)
Patients suffering from vestibulitis, furuncle, severe D.N.S, nasal polyp.
Systemic:
1)
Patients suffering from other systemic diseases like uncontrolled D.M., HTN.
2)
Pregnant woman and lactating mother.
3)
Patients suffering from autoimmune disorders.
4)
Any other acute infection / febrile illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of trial drug on allergic rhinitis on assessment criteria- Excellent/ Moderate Improvement / Mild Improvement / Ineffective |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Kshavakadi taila nasya & Brihad dadimashatk churna with Anu taila nasya & Vyoshadi vati in the management of Kaphaj Pratishyaya with special reference to allergic rhinitis.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Null Hypothesis There is no role of Kshavakadi taila nasya 4-8 drops OD of 2 settings with 7 days interval and Brihad dadimashatak churna 3gm BD for 30 days in the management of Kaphaj Pratishyaya with special reference to Allergic rhinitis. Alternative Hypothesis H1 There is significant effect of Kshavakadi taila nasya 4-8 drops OD of 2 settings with 7 days interval and Brihad dadimashatak churna 3gm BD for 30 days in Kaphaj Pratishyaya with special reference to Allergic rhinitis. Alternative Hypothesis H2 Kshavakadi taila nasya 4-8 drops OD of 2 settings with 7 days interval and Brihad dadimashatak churna 3gm BD for 30 days have better effect than Anu taila nasya 4-8 drops OD of 2 settings with 7 days interval and Vyoshadi vati 250mg BD for 30 days in Kaphaj Pratishyaya with special reference to Allergic rhinitis. Selected 150 patients will be randomly distributed into two equal groups each comprising 75 patients.
Group will be named as Group A and Group B. Group A will be trial group. Group B will be control group. 1) Trial group (Group A) Randomly selected 75 patients will be treated with Kshavakadi taila nasya and Brihad dadimashatk churna Nasya Dose - 4-8 drops OD for 7 days (2 settings with 7 days interval) Time – at morning Brihad dadimashatk churna – 3gm BD for 30 days. 2) Control group (Group B) Randomly selected 75 patients will be treated with Anu taila nasya and Vyoshadi Vati. Nasya Dose -4-8 drops OD for 7 days (2 settings with 7 days interval) Time – at morning Vyoshadi Vati – 2 BD (250mg each) For 30 days Each patient included in the study will be given treatment for 30 days. Follow up on – 15th, 29th, 60th day of study. Study will be carried out in 3 years duration of Ph.D. On each step data will be recorded. observation, discussion and conclusion are drawn from statastical analysis. |