| CTRI Number |
CTRI/2025/08/092836 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of beheda churna vati in cough. |
|
Scientific Title of Study
|
Comparative control clinical study to evaluate efficacy of Bibhitak (Terminalia bellirica) Churn vati in cough |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
swapnil nanabhau done |
| Designation |
3rd Year BAMS(UG) student |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 |
| Address |
Opd No 9 Sanshodhan Vibhag aarogyashala rugnalaya ganeswadi panchavati nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8856974939 |
| Fax |
|
| Email |
swpnildone@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shishir P Pande |
| Designation |
HOD department of rasashastra and bhaishajyakalpana |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 |
| Address |
OPD No 9 Sanshodhan Vibhag aarogyashala rugnalaya ganeshwadi panchavati nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9420830818 |
| Fax |
|
| Email |
shishir.nsk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shishir P Pande |
| Designation |
HOD department of rasashastra and bhaishajyakalpana |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 |
| Address |
OPD No 9 Sanshodhan Vibhag aarogyashala rugnalaya ganeshwadi panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9420830818 |
| Fax |
02532513112 |
| Email |
shishir.nsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra University of Health Sciences,Nashik under the scheme of STRG |
|
|
Primary Sponsor
|
| Name |
Maharashtra University of Health Sciences,Nashik under the scheme of STRG |
| Address |
Dindori road Mhasrul Mashik |
| Type of Sponsor |
Other [Health University] |
|
|
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 Shishir P Pande |
Arogyashala Rugnalaya |
OPD No 9 Aarogyashala rugnalaya Ganeshwadi Panchavti Nashik
Nashik
MAHARASHTRA |
9420830818
shishir.nsk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bibhitak churna vati, Reference: Ashtang hriday chikitsa 3/174, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Cofsils lozenges | cofsils lozenges for chewing 4 times a day |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and females between 18 to 60 years of age (both inclusive)
2. Subject suffering from uncomplicated cough that does not require antibiotic treatment.
3. The onset time should not be more than 3 days.
4. Willing to sign informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Cough caused by bronchial asthma, tuberculosis, bronchiectasis, and other diseases that have been clearly diagnosed as chronic obstructive pulmonary disease and/or severe respiratory tract infection.
2. Patient with known current lung cancer and fibrosis of lung.
3. Patients with uncontrolled diabetes or hypertension.
4. Women during pregnancy or lactation or women who are preparing for pregnancy or lactation during the trial.
5. Subjects with known current serious illness, eg, multisystem failure, chronic liver disease, HIV, cancer, renal failure, serious cardiovascular disease.
6. Known allergy to any ingredient of study products.
7. Any other conditions, which in the opinion of the investigator/s, makes the patient unsuitable for enrollment or could interfere with his/her participation and completion of the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To study the Anti-inflammatory effect of Bibhitak Churna Vati in pharyngitis having Cough. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study soothing effect of Bibhitak Churna Vati in Cold.
2) To assess the effect of Bibhitak Churna Vati in dry and wet cough.
3) To study the anti microbial properties of Bibhitak Churna Vati in Cough.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/08/2025 |
| 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="0"
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
|
Due to change in life style immunity of human being is decreasing spontaneously. At the same time pollution is becoming a big issue day by day this changes are affecting human health, cough, pharangitis, asthama, allergic bronchitis and respiratory disorders are found common in the society specially after Covid-19. There are so many formulations available to treat Cough in market. In Ayurveda simple remedies are mentioned to treat Cough, Asthama and respiratory disorders. As per Astanghridayama a single herb Bibhitak (Terminaliabellirica) is advice for the treatment of Cough, Asthama, Bronchitis. Bhibhitak (Terminalia bellirica) is cheapest medicine, freely available everywhere in India. Need to be tested for efficacy in Cough hence the purpose study is undertaken.We can control cough during the Purvaroopavastha to avoid further progress. The purvaroop mentioned in Ayurveda are pricking pain in the throat i.e.Shukpurnagalasyata, itching in the throat, changes in the voice, etc.Cough is common symptom seen due to pollution now a day. Many formulations are available to treat the same but they are not cost effective. Everyone is not able to afford it. Bibhitak churna vati is a specific formulation consisting of only one herb and that is why it is so cost effective to afford by poor, needy patients. The drug is proven for its antimicrobial and anti inflammatory activity. The formulation is handy chewable. |