| CTRI Number |
CTRI/2024/09/073678 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Study of Kshara and Lavana formulation of Kantakari and their Clinical Efficacy in Bronchial Ashthma as Add-on Therapy |
|
Scientific Title of Study
|
A Comparative Pharmaceutico – Analytical Study of Kshara and Lavana of Kantakari (Solanum virginianum L.) and to Evaluate their Clinical Efficacy as an Add-on Therapy in Bronchial Ashthma |
| 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 Jeel N Patel |
| Designation |
M.D. Scholar |
| Affiliation |
Government Ayurved College and Hospital, Vadodara |
| Address |
Upgraded department of Rasashastra and Bhaishajya Kalpana
Government Ayurved College, Ajwaroad, Dhanvantari marga, Panigate, Vadodara, Gujarat 390019 India
Vadodara
GUJARAT
390019
India |
| Phone |
7046126193 |
| Fax |
|
| Email |
jeelptl3998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Umretia |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College and Hospital, Vadodara |
| Address |
Upgraded department of Rasashastra and Bhaishajya Kalpana
Government Ayurved College, Ajwaroad, Dhanvantari marga, Panigate, Vadodara, Gujarat 390019 India
Vadodara
GUJARAT
390019
India |
| Phone |
7600011944 |
| Fax |
|
| Email |
dr.bhartiumrethia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeel N Patel |
| Designation |
M.D. Scholar |
| Affiliation |
Government Ayurved College and Hospital, Vadodara |
| Address |
Upgraded department of Rasashastra and Bhaishajya Kalpana
Government Ayurved College, Ajwaroad, Dhanvantari marga, Panigate, Vadodara, Gujarat 390019 India
Vadodara
GUJARAT
390019
India |
| Phone |
7046126193 |
| Fax |
|
| Email |
jeelptl3998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved college and Hospital, Ajwa road, Dhanvantari marg, Panigate, Vadodara 390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved Hospital Vadodara |
| Address |
Government Ayurved Hospital, Ajwa road, Dhanvantari marg, Panigate, Vadodara 390019 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeel N Patel |
Government Ayurved Hospital, Vadodara |
PG 1 OPD No: 22 and IPD Government Ayurved Hospital, Vadodara-390019, Vadodara
Vadodara
GUJARAT |
7046126193
-
jeelptl3998@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Commitee, Government Ayurved College and Hospital, Vadodara |
Approved |
| Institutional Human Ethics Commitee, Government Ayurved College and Hospital, Vadodara |
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: Kantakari Kshara, Reference: Ayurveda Sara Samgraha- Kshara, Lavana and Satva Prakarana, Pg no: 700, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Warm water), Additional Information: Patients takes Ayurvedic interventional medicine with his/her ongoing conventional medicines(whatever used by patient for bronchial ashthma.) Followup 4 week after treatment | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kantakari Lavana, Reference: Anubhuta (Reference of method of preparation: Rasa Tarangini: 14/131-132), Route: Oral, Dosage Form: Lavana, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Warm water), Additional Information: Patients takes Ayurvedic interventional medicine with his/her ongoing conventional medicines(whatever used by patient for bronchial ashthma.) Followup 4 week after treatment |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Asthma since more than one year.
2. Patients on stable medication for one month.
3. Patient with partially or uncontrolled symptoms and/or FEV1 50-80% of predicted
|
|
| ExclusionCriteria |
| Details |
1. Age below 18 years and above 70 years.
2. Uncontrolled hypertension, diabetes or chronic systemic diseases
3. Cardiac diseases (IHD, CCF, DCM, RHD etc.)
4. Patient with respiratory infections in past one month.
5. Exacerbation in past one month
6. Patient with active tuberculosis, HIV etc
7. Patients with major systemic illness
8. Pregnant and lactating mothers
9. Any malignancy
10.Presence of other pulmonary disease like emphysema, cystic fibrosis etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Dyspnoea and Cough |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in all symptoms |
28 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/11/2024 |
| Date of Study Completion (India) |
05/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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)
|
The clinical study was conducted following approval from the institutional ethics committee (GAC/VDD/IEC/94/2024) and registered with the clinical trial registry of India CTRI/2024/09/073678, registered on 10/09/2024. This was an open labelled parallel arm randomized clinical trial in Bronchial Asthma. The patient was diagnosed based on the presence of one or more symptoms specified in GINA. The effect of the therapy was evaluated using subjective criteria such as Dyspnoea, Cough, Wheezing and Chest tightness and Objective criteria such as Dyspnoea, Cough, FEV1, PEFR, BHT and ACT after treatment. Symptoms was assess using scoring pattern. 54 subjects were randomized into 2 groups: Group A : Kantakari Kshara (KK) with conventional medicine and Group B: Kantakari Lavana (KL) with conventional medicine. 27 patients enrolled in each group among them 2 patients were dropped out in each group, remaining 25 patients in each group completed their treatment. KK and KL were administered in 500 mg BD dose with warm water after breakfast and dinner for 4 week. After 4 weeks follow up was done. After statistical analysis highly significant (p<0.001) improvement was found in both groups in all parameters. Among subjective criteria Dyspnoea improved by 71.23% Group A and 69% in Group B, cough by 82.19% and 83%, wheezing by 77.98% and 91.2% and chest tightness by 83% and 76% respectivelly. Among objective parameters Dyspnoea improved by 52.66% and 54.66%, Cough by 72.81% and 75.83%, FEV1 by 18.08% and 15.34%, PEFR by 29.35% and 31%, BHT by 46.73% and 76.98% and ACT by 24.19% and 34.28% in Group A and Group B respectivelly. No statistically significant difference (p>0.05) was observed in both groups. No any adverse drug event was observed during Ayurvedic medicine used with conventional therapy of patient in Bronchial Asthma as an add on therapy. |