| CTRI Number |
CTRI/2025/01/079784 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the efficacy of an Ayurvedic formulation (Mahakalyanak Gud) in the management of Pratishyaya (Cold) in the children of age group 2 to 10 years. |
|
Scientific Title of Study
|
A randomized controlled clinical trial to assess the efficacy of Mahakalyanak Gud in the management of Pratishyaya in the children of age group 2 to 10 years. |
| 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 Sejal Uddhav Gawade |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre
Balrog Department
Third floor
Nigdi
Pune 411044
Maharashtra
India
PDEAs College of Ayurved and Research Centre
Balrog Department
Third floor
Nigdi
Pune 411044
Maharashtra
India
Pune
MAHARASHTRA
411044
India |
| Phone |
8788390927 |
| Fax |
|
| Email |
sejalgawade1001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurved and Research |
| Address |
PDEAs College of Ayurved and Research Centre
Balrog Department
Third floor
Nigdi
Pune 411044
Maharashtra
India
PDEAs College of Ayurved and Research , Balrog Centre Department, Third floor, Nigdi, Pune 411044
Maharashtra
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurved and Research |
| Address |
PDEAs College of Ayurved and Research Centre
Balrog Department
Third floor
Nigdi
Pune 411044
Maharashtra
India
PDEAs College of Ayurved and Research , Balrog Centre Department, Third floor, Nigdi, Pune 411044
Maharashtra
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and Research Centre Sector no 25 Nigdi Pradhikaran Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEA College of Ayurved and Research Centre Niigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre
Balrog Department
Third floor
Nigdi
Pune 411044
Maharashtra
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 Sejal Gawade |
Ayurved Rugnalaya and sterling multipeciality hospital |
Ayurved Rugnalaya and sterling multipeciality hospital Nigdi Pradhikaran Pune Sector no 27 Balrog department OPD No 118 Pune
Pune
MAHARASHTRA |
8788390927
sejalgawade1001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahakalyanak Gud, Reference: Vangsen Samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 230(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: In Pediatrics, doses are calculated according to the weight. Dose given will be 230mg/kg/dose three times a day for 7 days. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bharangi Syrup, Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1.6(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: In Pediatrics, dose is calculated according to the weight. Dose given will be 1.6ml/kg/day in two divided doses for 7 days. |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children suffering from Pratishyaya having at least 3 symptoms from the following-
Nasastrava, Nasanaha, Shirashool, Kshavathu,Swarbheda, Ghranopradha, Kandu, Aruchi
2. Children in the age group of 2 to 10 years will be selected irrespective of religion and gender. |
|
| ExclusionCriteria |
| Details |
1. K/C/O Kochs, COPD
2. K/C/O Sinusitis, Deviated Nasal septum
3. K/C/O Congenital diseases of respiratory tract
4. Nasal polyp
5. Raktaj, Dushtaj and Sannipataj pratishyaya |
|
|
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 |
| To assess the efficacy of Mahakalyanak Gud in the management of Pratishyaya on the basis of the symptoms like Nasastrava, Nasanaha, Nasaopradha, aruchi, etc. for 7 days. |
7 days where follow up will be on 3rd, 5th and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the side effects if any |
7 days where follow up will be on 3rd, 5th and 7th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="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
|
Pratishyaya is one of the most important and commonly occurring diseases among the Nasa rogas. It is the common disease of respiratory tract occurring all over the world affecting all humans irrespective of age and gender. Pratishyaya is very common in children due to exposure to allergens, pollution and dust; altered dietary habits. If not treated in earlier stage, it gives rise to complications such as Badhirya, Kasa, Shwas etc. It is also the causative factor of other diseases. The rate of prevalence is up to 40%. It can be co-related with Rhinitis with its clinical manifestations. The disease is characterized by Nasastrava, Nasanaha, Kshavthu, Shirashool, Jwara, Kandu, Kasa,Swarbheda, Ghranopradha, Aruchi. Management of Pratishyaya in children needs more care and observation as it may lead to further complications. So, the research should be fast acting, effective and safe medicines with easy administration. Properties of ’Mahakalyanak Gud’ are Deepaniya, Pachniya, Pratishyayahar, etc. Considering the palatability, this preparation is made in Avaleha form. So, it is selected to find out the efficacy in the management of Pratishyaya in children of age group 2 to 10 years. |