| CTRI Number |
CTRI/2025/06/088229 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Understanding the Causes and Body Types in Asthma (Tamaka Shwasa) and Comparing the Effects of Two Ayurvedic Herbs – Pushkarmula and Somlata – in Its Treatment. |
|
Scientific Title of Study
|
The conceptual study of Nidan & Deha Prakriti in relation to Tamaka Shwasa w.s.r. to Bronchial Asthma and its management with Pushkarmula (Inula racemosa Hook. f. ) in comparison to Somlata (Ephedra gerardiana Wall |
| 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 Akhilesh Kumar Srivastava |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital |
| Address |
Department of Rog nidan Anatomy Block Room No 104 Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Kangra
Himachal Pradesh
176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
6230118318 |
| Fax |
|
| Email |
drakhilesh.srivastava@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Kumar Srivastava |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital |
| Address |
Department of Rog nidan Anatomy Block Room No 104 Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Kangra
Himachal Pradesh
176115
India
HIMACHAL PRADESH
176115
India |
| Phone |
6230118318 |
| Fax |
|
| Email |
drakhilesh.srivastava@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Kumar Srivastava |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital |
| Address |
Department of Rog nidan Anatomy Block Room No 104 Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Kangra
Himachal Pradesh
176115
India
HIMACHAL PRADESH
176115
India |
| Phone |
6230118318 |
| Fax |
|
| Email |
drakhilesh.srivastava@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Govt. Post Graduate Ayurvedic College And Hospital Paprola District Kangra himachal pradesh Pin Code 176063 India |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College And Hospital Paprola District Kangra |
| Address |
Department Of Rog nidan RGGPG Ayurvedic College And Hospital Paprola District Kangra Himachal Pradesh Pin Code 176063 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Akhilesh Kumar Srivastava |
Room no 104 Department of Rognidan Anatomy block RGGPG Ayurvedic College And Hospital Paprola |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dichen Angmo |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola |
Department of Rognidan OPD No 208
Kangra
HIMACHAL PRADESH |
7018293394
angmodichen35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J709||Respiratory conditions due to unspecified external agent. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: pushkarmula vati, Reference: bhavprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -ushan jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: somlata vati, Reference: bhavprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -ushan jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria. 2. Patients willing to participate in the trial. 3. Patient in the age group between 16–70 years
4. Patients with mild to moderate presentation in symptoms.
|
|
| ExclusionCriteria |
| Details |
Patients not willing for the clinical trial. Patients below 16 years and above 70 years of age. Patients suffering from jaundice , anaemia ,hepatitis ,chronic renal disorders , chronic infectious and Other serious disease Pregnant ladies and lactating mothers. Patients suffering from diseases like other chronic respiratory like status asthmaticus, cardiac, hepatic and hormonal disease Any other condition which the principal investigator thinks may jeopardize the study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effects of Pushkarmula and Somlata in reducing asthma symptoms (Tamaka Shwasa).
To observe improvement in breathing problems, such as wheezing, coughing, and shortness of breath.
To study how different body types (Deha Prakriti) influence asthma and its treatment.
To identify common causes (Nidan) that trigger or worsen asthma in patients |
Day 0: Baseline assessment, Prakriti analysis, start treatment.
Day 14: First follow-up, symptom check, side effects.
Day 28: Second follow-up, reassess symptoms and progress.
Day 42: Third follow-up, monitor changes.
Day 56: Final evaluation, compare outcomes, end of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of this study includes assessing the long-term sustainability of symptom relief, impact on quality of life, and changes in Prakriti-based response patterns. It also evaluates the safety profile of Pushkarmula and Somlata, reduction in the use of conventional medications, and influence on Nidan (causative factors) in disease progression. |
The secondary outcome assessment will be conducted at key time points:
Baseline (Day 0): Evaluation of quality of life, Prakriti influence, and dependency on conventional medication.
Week 4: Mid-study review of symptom sustainability and safety profile.
Week 8 (Final Assessment): Analysis of long-term symptom relief, medication reduction, and impact on Nidan factors. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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 study explores the concept of Nidan (causative factors) and Deha Prakriti (body constitution) in relation to Tamaka Shwasa (Bronchial Asthma) through an Ayurvedic perspective. Tamaka Shwasa, a chronic respiratory disorder, is influenced by various dietary, lifestyle, and environmental factors, along with an individual’s Prakriti, which determines their susceptibility to the disease. The research aims to compare the efficacy of two Ayurvedic herbs—Pushkarmula (Inula racemosa) and Somlata (Ephedra gerardiana)—in the management of Tamaka Shwasa. While Pushkarmula is known for its anti-inflammatory and bronchodilator properties, Somlata is traditionally used for its rapid asthma-relieving effects. The study evaluates their impact on symptom relief, lung function, and overall quality of life, while also analyzing how different Prakriti types respond to these treatments. By correlating Nidan and Prakriti with disease manifestation and management, this research aims to provide insights into personalized Ayurvedic treatment approaches for Bronchial Asthma. |