| CTRI Number |
CTRI/2026/01/101963 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial of Guda Vati with tablet Doxophylline in Bronchial Asthma |
|
Scientific Title of Study
|
An open labelled randomized controlled trial to evaluate the efficacy of Guda Vati with tablet Doxophylline in Tamakshwasa 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 YOGESH TUKARAM KOTANGALE |
| Designation |
Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO 2
First Floor
Kayachikitsa Department
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
09423218193 |
| Fax |
|
| Email |
drytk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rushikesh Vilas Lande |
| Designation |
PG SCHOLAR |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO 2
First Floor
Kayachikitsa Department
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
7039626286 |
| Fax |
|
| Email |
landerushikesh234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rushikesh Vilas Lande |
| Designation |
PG SCHOLAR |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO 2
First Floor
Kayachikitsa Department
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
7039626286 |
| Fax |
|
| Email |
landerushikesh234@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai Shah Ayurved College Malwadi Hadapsar Pune Maharashtra State India 411028 |
|
|
Primary Sponsor
|
| Name |
Dr Rushikesh Vilas Lande |
| Address |
MAMs Sumatibhai Shah Ayurved College Malwadi Hadapsar Pune Maharashtra State India 411028 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rushikesh Vilas Lande |
Saneguruji Arogya Kendra |
OPD NO 2
First Floor
Kayachikitsa OPD
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA |
7039626286
landerushikesh234@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:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Doxophylline | 200mg bid | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guda vati, Reference: Sharngdhar samhita,, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having classical signs and symptoms of Tamakashwasa in Avegavastha and symptoms of mild to moderate nature.
2. Patients with known case of Bronchial Asthma having signs and symptoms of mild to moderate nature from more than one year.
3. PEFR more than 300 liters per min
4. Age: 19 to 60 Years.
5. Gender: Irrespective to gender |
|
| ExclusionCriteria |
| Details |
1. Pregnant woman Lactating mothers .
2. Cardiac Asthma, Uncontrolled Diabetes Mellitus and Hypertension
3. Patients taking Inhaler daily will be excluded.
4. Patient of Tamakshwasa with secondary infections. Patient suffering from
systemic disorders like Tuberculosis, Emphysema, Cor-Pulmonale, etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Guda Vati 1gm twice a day when
compared with Tablet Doxofylline 200mg in reduction of symptoms
of Tamakshwasa over the period of 21 days |
base line 0 days, 7 days, 14 days, 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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/ Phase 3 |
|
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="2" |
|
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
|
Asthma is a substantial global health problem, with increasing prevalence rates in
many countries. According to World Health Organization (WHO) estimates, 300
million people have asthma and 255000 died of asthma in 2005; over 80% of asthma
deaths occur in low- and lower-middle-income countries. Prevalence in India-
It has previously been estimated that the prevalence of asthma in India is about 3%
(30 million patients) with a prevalence of 2.4% in adults aged >15 years, and between
4% and 20% in children. In 2004, it was estimated that 57 000 deaths in India were
attributed to asthma; it is one of the leading causes of morbidity and mortality in rural India and is projected to increase in the coming decades. |