| CTRI Number |
CTRI/2025/12/098830 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| 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
|
To compare Nidigdhikadi Yoga versus Shatyadi Churna in Bronchial Asthma |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study to Evaluate the Efficacy of Nidigdhikadi Yoga and Shatyadi Churna in the Management of Tamaka Shwasa with Special Reference to Bronchial Asthma. |
| 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 Randhir |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 56, Ground Floor, Institute for Ayurved Studies and Research Shri
Krishna AYUSH University Umri Road, Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
7206212786 |
| Fax |
|
| Email |
randhirkataria666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Kumari |
| Designation |
Chaiperson & HOD PG Department of Kayachikitsa |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 70, Ground Floor, Institute for Ayurved Studies and Research Shri
Krishna AYUSH University Umri Road, Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Kumari |
| Designation |
Chaiperson & HOD PG Department of Kayachikitsa |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 70, Ground Floor, Institute for Ayurved Studies and Research Shri
Krishna AYUSH University Umri Road, Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies & Research Shri Krishna AYUSH University |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies & Research Shri Krishna AYUSH University |
| Address |
Sector 8 Umri Road Kurukshetra 136118 Haryana India |
| 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 |
| Dr Randhir |
Institute For Ayurved Studies and Research |
Room no 56, Ground Floor, Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road, Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA |
7206212786
randhirkataria666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NIDIGDHIKADI YOGA, Reference: Sushruta samhita Uttar Tantra 51/55, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHATYADI CHURNA, Reference: Charak Samhita Chikitsa Sthan 17/56-57, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing for clinical trial and ready to give written Consent.
2. Patients between the age group of 30-60 years of either sex.
3. Patients fulfill the diagnostic criteria of Tamaka Shwasa (Bronchial Asthma).
4. Patients presented with cardinal features of Tamaka Shwasa as described in Ayurveda texts.
5. Newly Diagnosed and confirmed cases of Tamaka Shawasa (Bronchial Asthma) on the basis
of criteria given by NAEPP. |
|
| ExclusionCriteria |
| Details |
1. Patient not willing to Clinical Trial
2. Patients not fulfilling the Inclusion Criteria
3. Patient having an Age below 30 and Above 60.
4. Patients having a medical history of CHF, CAD, Pulmonary hypertension, Diabetes Mellitus, Uncontrolled hypertension, CKD, and Autoimmune disorders.
5. During Pregnancy, Lactation period.
6. 7. Patients on Steroid therapy, Inhaler or any other medicines.
Patient Suffering from Secondary Respiratory Disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in lung function: Measure changes in FEV1 (Forced Expiratory Volume in 1second),FVC,FVR or PEFR (Peak Expiratory Flow Rate).
2. Change in intensity and severity of Rhonchi and Wheeze.
3.Change in intensity and severity in the symptoms of Tamaka Shwasa. |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of the interventions on biochemical markers such as absolute eosinophil count and inflammatory indices(ESR and CRP).
2. Exacerbation frequency: Track changes in frequency of asthma exacerbations. |
21 Days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
02/03/2026 |
| 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="6"
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 randomized, open-label, parallel-group clinical trial will assess and compare the efficacy of two classical Ayurvedic formulations, Nidigdhikadi Yoga and Shatyadi Churna, in the management of Tamaka Shwasa (Bronchial Asthma). Sixty-six eligible participants will be randomly assigned into two groups. Group A will receive Nidigdhikadi Yoga 5 g twice daily before meals with honey, and Group B will receive Shatyadi Churna 5 g twice daily before meals with honey, for 21 days, followed by post-treatment follow-up until Day 42. Outcome evaluation will be performed using standardized subjective symptom scoring, spirometry parameters (FEV1, FVC, FEV1/FVC ratio, and PEFR), and inflammatory indices including absolute eosinophil count, ESR, and CRP. All participants will be advised appropriate pathya–apathya (dietary and lifestyle regimen) during the study. Institutional Ethics Committee (IEC) approval has been obtained and written informed consent will be taken prior to enrolment. The primary objective is to determine comparative improvement in asthma severity, respiratory function, and clinical response between the two interventions. |