| CTRI Number |
CTRI/2026/02/103410 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| 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
|
Effect of nagaradi modak in the management of vataj kasa (acute bronchitis) |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of nagaradi modak in the management of vataj kasa (acute bronchitis) |
| 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 Ashutosh Prabhakar Shinde |
| Designation |
Pg Scholar |
| Affiliation |
C.S.M.S.S Ayurved mahavidyalaya and rugnalaya |
| Address |
OPD NO. 13, kayachikitsa department, C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi, Aurangabad, 431011
Aurangabad
MAHARASHTRA
431011
INDIA
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9975847998 |
| Fax |
|
| Email |
ashutosh1997shinde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikant Gunwantrao Deshmukh |
| Designation |
HOD Professor |
| Affiliation |
C.S.M.S.S Ayurved Mahavidhyalaya and Rugnalaya |
| Address |
OPD NO. 13, kayachikitsa department, C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi, Aurangabad, 431011
Aurangabad
MAHARASHTRA
431011
INDIA
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9921553999 |
| Fax |
|
| Email |
dr.shrikantgdeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Prabhakar Shinde |
| Designation |
Pg Scholar |
| Affiliation |
C.S.M.S.S Ayurved mahavidyalaya and rugnalaya |
| Address |
OPD NO. 13, kayachikitsa department, C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi, Aurangabad, 431011
Aurangabad
MAHARASHTRA
431011
INDIA
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9975847998 |
| Fax |
|
| Email |
ashutosh1997shinde@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no.13 kayachikitsa department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi , aurangabad 431011 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S Ayurved Mahavidhyalaya and Rugnalaya Aurangabad |
| Address |
OPD NO. 13, kayachikitsa department, C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi, Aurangabad, 431011
Aurangabad
MAHARASHTRA
431011
INDIA
|
| Type of Sponsor |
Private 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 Ashutosh Prabhakar Shinde |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
OPD NO. 13, kayachikitsa department, C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi, Aurangabad, 431011
Aurangabad
MAHARASHTRA
431011
INDIA
Aurangabad
MAHARASHTRA |
9975847998
ashutosh1997shinde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S. Ayurveda And Mahavidyalaya Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J209||Acute bronchitis, unspecified. Ayurveda Condition: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NAGARADI MODAK, Reference: Sahastrayoga Shloka no 46 page no 182, Route: Oral, Dosage Form: Modaka , Dose: 10(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SITOPALADI CHURNA, Reference: Charak Samhita Chikitsasthan Adhay 8 Shloka no 103-104, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of Age group 18 to 45 yrs.
2. Patients irrespective of Gender, Religion ¸Profession, Marital status and Socioeconomic status.
3. Patients showing Classical Lakshanas of Vataj Kasa that mentioned in Samhita.
|
|
| ExclusionCriteria |
| Details |
1. Patient with other severe systemic disorder and also sign and symptoms other than Vataj Kasa.
2. Patient with known respiratory disorder like Tuberculosis, COPD, Asthma, CA lungs any any other known respiratory disease.
3. Pregnant and lactating mothers.
4. Patient below age group 18 years & above 60 years will be excluded
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Shushka Kasa (Dry Cough)
2. Shirashoola (Headache)
3. Uraha shoola (Chest pain)
will be reduced |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Daurabalya (General Weakness)
2. Parshwashoola (Pain in thoracic region)
will be reduced
|
14 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/02/2026 |
| 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
|
Kasa
(cough) is of five type i.e. Vataja Kasa, PattajaKasa ,Kaphaja Kasa ,kshataja
Kasa, kshayaja Kasa in successive order’.
Vataja Kasa (cough) may originate due to
Nidan (aetiology) like dry, cold, and vataprakopakaahar
(astrigent
food items )vegdharana (suppression of natural urges) and Atishrama (excessive
physical strain)and other causes like dust, smoke, or pollen grains etc.[3]
Due to
vitiated vata dosha in vatajakasa, following symptoms are seen:- swarbhed(Hoarseness
of voice), Urahsool (pain in chest), Shirahsool (Head ache), Parshvasool (pain
in lateral side of chest), Sushka Kasa (dry cough) with litle
expectoration.Thus the drug which is vatashamaka (minimise) or stop irritation
can subside vatajkasa symptom is beneficial [4]
Acute
bronchitis can be caused by allergens,irritants ,and bacteria Irritants include
smoke inhalation, dust,amongothers .[6].
Acute bronchitis shows symptoms like dry
cough, sore throat, headache, chest
soreness which are similar to vatajkasa .[7]
So,vatajkasa
is taken with special reference to acute bronchitis.
In india
the prevalence of vatajkasa is 5% in diverse situations.[9]Vataj Kasa
is notably widespread and is recognized as a troubling condition (Kasa Vyadhi)
that affects individuals across all age groups. It causes significant
discomfort, not just physically but also impacts mental and social wellbeing.
Ayurveda offers a rich heritage of herbal and mineral remedies that have
demonstrated impressive results. These treatments are known for their rapid
effectiveness, high potency, and are available in user-friendly dosage forms
which leads to convenience in administration. |