| CTRI Number |
CTRI/2026/01/100507 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| 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
|
A study on Drakshadyavaleha and Devadaru syrup in the management of Bronchial Asthma in childen. |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Clinical Trial to Evaluate the Efficacy of Drakshadyavaleha and Devadaru Syrup
in the Management of Tamaka Shwasa w.s.r. Bronchial Asthma in Children. |
| 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 Karam Singh |
| Designation |
Senior Lecturer |
| Affiliation |
RGGPG Ayurvedic college and Hospital, Paprola. |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Distt Kangra, Himachal Pradesh.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018708912 |
| Fax |
|
| Email |
singhverma2024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karam Singh |
| Designation |
Senior Lecturer |
| Affiliation |
RGGPG Ayurvedic college and Hospital, Paprola. |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Distt Kangra, Himachal Pradesh.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018708912 |
| Fax |
|
| Email |
singhverma2024@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagrika Prakash |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic college and Hospital, Paprola. |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Distt Kangra, Himachal Pradesh.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219502367 |
| Fax |
|
| Email |
sagrikaprakas33@gmail.om |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola, Distt Kangra,Himachal Pradesh 176115, Herbal Garden and Herbarium, Research Institute in ISM Joginder Nagar, Distt Mandi, Himachal Pradesh. |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Distt Kangra 176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Karam Singh |
RGGPG Ayurvedic college and Hospital, Paprola. |
Department of Kaumarbhritya RGGPG Ayurvedic College and Hospital, Paprola, Distt Kangra, Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH |
07018708912
singhverma2024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE(HUMAN) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J45||Asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshadyavaleha, Reference: sushrut uttar tantra 51/40, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Devadaru Syrup, Reference: charak chikitsa 17/105, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Syrup Levosalbutamol | Route of administration - Oral administration.
Dose - 0.05mg-0.2mg/kg/dose BD
Duration - 3 weeks
|
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children between the age group of 8 to 16 years.
Patients of mild to moderate severity of Bronchial Asthma.
Only stable cases of Bronchial Asthma (as per WHO GINA guideline) for at least 6 weeks prior to study.
Parents/guardians of the children willing to participate in the research trial.
|
|
| ExclusionCriteria |
| Details |
Children aged below 8 and above 16 years.
Patients having Status asthmaticus condition, presenting systemic illness like Pneumonia, Pleural Effusion, Pulmonary T.B.,etc.,and patient who is suffering from any congenital or hereditary illness.
Patients with PEFR less than 60%.
Patients on prolonged (more than 6 weeks) medication with corticosteroids, bronchodilators, etc.
Parents or guardians of the children not willing to participate in the research trial.
Any other condition which the principal investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Drakshadyavaleha and Devadaru Syrup in the management of Tamaka Shwasa.
To compare the efficacy of Drakshadyavaleha and Devadaru Syrup with Syrup Levosalbutamol in the management of Tamaka Shwasa.
|
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To establish a safe & cost-effective medicine for the treatment of Tamaka Shwasa.
To evaluate the safety of both the drugs in children.
|
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/04/2026 |
| 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="0"
Months="0"
Days="21" |
|
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
|
I would like to publish my research trial after completion as soon as possible. A total of 40 subjects will be studied in two groups. 20 study subjects with both Drakshadyavaleha and Devadaru syrup and 20 study subjects with Syp Levosalbutamol for a period of 3 weeks. The outcome will be analysed based on subjective and objective parameters with appropriate statistic tools. |