| CTRI Number |
CTRI/2026/01/100585 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Assess the effect of Shatyadi Leha With Panchalavana Siddha Ghrita Nasya and Yava Sattu Churna Dhoompana in Children of Vataj Pratishyaya correlated to Allergic Rhinitis |
|
Scientific Title of Study
|
An Open Label Randomised Clinical Trial to Evaluate and Compare the Efficacy of
Shatyadi leha with Yava Sattu Churna Dhoompana and Panchalavana Siddha Ghrita
Nasya on Vataja Pratishyaya w.s.r. to Allergic Rhinitis in Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Rakesh Sharma |
| Designation |
Prof and Head, Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra,Himachal Pradesh Pando Road, Teh-Baijnath, Distt-Kangra, HP,Pin-176115 India
RGGPG Ayurvedic College and Hospital, Paprola, Tehsil Baijnath, District Kangra, HP 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418105049 |
| Fax |
|
| Email |
hodkbpaprola8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rakesh Sharma |
| Designation |
Prof and Head, Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra,Himachal Pradesh Pando Road, Teh-Baijnath, Distt-Kangra, HP,Pin-176115 India
RGGPG Ayurvedic College and Hospital, Paprola, Tehsil Baijnath, District Kangra, HP 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418105049 |
| Fax |
|
| Email |
hodkbpaprola8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devanshu Sharma |
| Designation |
MD Scholar |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola, Tehsil Baijnath ,District Kangra |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola,Tehsil Baijnath, District Kangra, HP, 176115
RGGPG Ayurvedic College and Hospital Paprola, Tehsil Baijnath, District Kangra, Himachal Pradesh, 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8825005946 |
| Fax |
|
| Email |
sdevanshu427@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola 176115,District Kangra,Herbal Garden And Herbarium, Research Institute in ISM, in Jogindernagar, 175015,District Mandi, HP, India |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital,Paprola, Kangra,HP,176115 |
| 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 Rakesh Sharma |
RGGPG Ayurvedic College |
RGGPG Ayurvedic College and hospital, Paprola, Tehsil Baijnath, District Kangra, HP,176115
Kangra
HIMACHAL PRADESH |
9418105049
hodkbpaprola8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) |
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, (2) ICD-10 Condition:J30||Vasomotor and allergic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatyadi Leha, Reference: Yogratnakar Nasaroga Chikitsa 7, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 700(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Weeks, anupAna/sahapAna: Yes(details: - Luke Warm Water), Additional Information: Dose is 700mg per kg per day in two divided doses | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatyadi Leha, Reference: Yogratnakar Nasaroga Chikitsa 7, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 700(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Weeks, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: Dose is 700 mg per kg per day in two divided doses | | 3 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hridya Uttarsthan 20/10, Procedure details: After obtaining Consent from parents or guardians of Participant He will be administered Panchlavana Siddha Ghrita Nasya through the nasal route. Prior to administration, the subject will be advised to lie in a supine position with mild neck extension after gentle facial massage and fomentation, as per classical Nasya protocol. The Panchlavana Siddha Ghrita will be slightly warmed to lukewarm temperature and 6 drops will be instilled into each nostril once daily, preferably in the morning hours. After instillation, the participant will be instructed to inhale gently and remain in the same position for a few minutes, followed by spitting out any residual drug reaching the oropharynx. The procedure will be continued daily for a duration of one week under supervision, with monitoring for any adverse effects throughout the intervention period.)
(1) Medicine Name: Panchalavana Siddha Ghrita, Reference: Ashtanga Hridya Uttarsthan 20/10, Route: Nasal, Dosage Form: Ghrita, Dose: 6(drops), Frequency: od, Duration: 7 Days | | 4 | Comparator Arm | Procedure | - | dhUmapAnam, धूमपानम् | (Procedure Reference: Charak Samhita Chiktsa Sthan 26/136, Procedure details: After proper counseling and baseline assessment, the participant will be advised to perform Yava Sattu Churna Dhoomapana once daily in the morning. Finely cleaned and dried Yava (barley) powder will be prepared in advance. Approximately 10 mg of the powder will be used for Snigdha Dhoomapana by controlled nasal inhalation and exhaled through mouth , 3 cycles will be repeated . The procedure will be performed under supervision during the initial sitting, and participants will be instructed regarding the correct method for subsequent days. The intervention will be continued for a duration of one week, and participants will be monitored for compliance, therapeutic response, and any adverse events throughout the study period)
(1) Medicine Name: Yava Sattu Churna, Reference: Charak Samhita Chikitsa Sthan 26/136, Route: Nasal, Dosage Form: Churna/ Powder, Dose: 10(mg), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient between 7 to 16 years of age.
2. Mild to moderate patients of Allergic Rhinitis will be included.
3. Parents/Guardians of the children willing to participate in the research trial.
|
|
| ExclusionCriteria |
| Details |
1. Patient below 7 years of age and above 16 years.
2. Patients suffering from rhinitis other than Allergic rhinitis like Dushta pratishyaya , Raktaja
pratishyaya, Acute / Chronic sinusitis and other nasal pathologies like Deviated nasal septum,
Nasal polyp , Nasal trauma
3. Children with congenital anomalies like Cleft palate, Cleft Lip etc.
4. Parents/Guardians of the children not willing to participate in the research trial. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To Evaluate the Efficacy of Yava Sattu Churna Dhoompana and Panchalavana Siddha Ghrita Nasya with Shatyadi leha on Vataja Pratishyaya in children.
2 To Compare the Efficacy of Yava Sattu Churna Dhoompana and Panchalavana Siddha Ghrita Nasya with Shatyadi leha on Vataja Pratishyaya in children. |
3 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess the Clinical Safety of Yava Sattu Churna Dhoompana and Panchalavana Siddha Ghrita Nasya
with Shatyadi leha on Vataja Pratishyaya in children. |
3 Weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2026 |
| 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
|
I Would Like to Publish my Research Trial after Completion As Soon As Possible . This study is an Open Label Randomised Clincal Trial Designed to Asses and Compare the Efficacy of Shatyadi Leha with Yava Sattu Churna Dhoompana and Panchalavana Siddha Ghrita Nasya in the Management of Vataja Pratishaya or Allergic Rhinitis in Children. A Total of 40 Subjects Will be Studied in Two Groups 20 Patients Will be Managed by Shatyadi Leha and Yava Sattu Churna Dhoompana and 20 Will be Managed by Shatyadi Leha and Panchalavana Siddha Ghrita Nasya.The Trial Aims to Evaluate Improvement in Clinical Symptoms, Quality of Life and Safety Profile of the Interventions, Participants Will be Assessed at Baseline, During treatment and at the End of the Study Using Predefined Objective and Subjective Outcome Measures |