| CTRI Number |
CTRI/2025/03/081888 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Duralbhadi Leha and Dusparshadi Leha and compare their action in the treatment of Vataj Kasa with reference to Dry cough. |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL STUDY TO COMPARE THE EFFICACY OF DURALABHADI LEHA AND DUSPARSHADI LEHA IN THE MANAGEMENT OF VATAJ KASA (DRY 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 |
Dr Girish Vijay solanki |
| Designation |
MD Kayachikitsa Scholar ( Ayurveda) |
| Affiliation |
DR VJD Gramin Ayurveda Mahavidyalaya |
| Address |
OPD No 3,Department of Kayachikitsa, DR VJD Gramin Ayurved Mahavidyalaya, Near Renuka Mata mandir, Patur Tq.patur Dist.Akola pin 444501 MAHARASHTRA INDIA
Near Renaka Mata mandir Patur Tq.patur Dist. Akola Maharashtra pin 444501
Akola
MAHARASHTRA
444501
India |
| Phone |
8668336489 |
| Fax |
|
| Email |
girishsolanki.gs1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJayashree Katole |
| Designation |
Professor and Head of the Department, Kayachikitsa |
| Affiliation |
DR VJD Gramin Ayurved Mahavidyalaya, Patur |
| Address |
OPD No 3,Department of Kayachikitsa, DR VJD Gramin Ayurved Mahavidyalaya, Near Renuka Mata mandir, Patur Tq.patur Dist.Akola pin 444501 MAHARASHTRA INDIA
Near Renuka Mata mandir Patur Tq.patur Dist.Akola pin 444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA
444501
India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJayashree Katole |
| Designation |
Professor and Head of the Department, Kayachikitsa |
| Affiliation |
DR VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD No.3, Department of Kayachikitsa, DR VJD Gramin Ayurved Mahavidyalaya, Near Renuka Mata mandir Patur Tq.patur Dist.Akola pin 444501 MAHARASHTRA INDIA
Near Renuka Mata mandir Patur Tq.patur Dist.Akola pin 444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA
444501
India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR VJD Gramin Ayurved Mahavidyalay, Patur Tq.patur Dist.Akola MAHARASHTRA INDIA
Pin 444501 |
|
|
Primary Sponsor
|
| Name |
DR VJD Gramin Ayurveda Mahavidyalaya |
| Address |
DR VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata mandir Patur Tq.patur Dist.Akola pin 444501 MAHARASHTRA INDIA
|
| 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 |
| DrGirish Vijay solanki |
Dr.VJD Gramin Ayurved Mahavidyalaya and Research centre |
OPD No.3 Department of Kayachikitsa Dr.VJD Gramin Ayurveda Mahavidyalaya Near Renuka Mata mandir Patur Tq.patur Dist.Akola pin 444501 MAHARASHTRA INDIA
Akola
Akola
MAHARASHTRA |
8668336489
girishsolanki.gs1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr VJD Gramin Ayurveda Mahavidyalaya patur Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R05||Cough. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Duralabhadi Leha, Reference: Charak chikitsa 18/50, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dusparshadi Leha, Reference: Charak chikitsa 18/51, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with symptoms of Vataj Kasa. (Kasa Vega, Hritshool, Parshwashool, Shirshool, Shushka Vaktra, Swarbhed)
2.Age group 18 years to 60 years.
3.Both the genders irrespective of their religion, socioeconomic status, occupation
4 Patents willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Known cases of Cancer, DM, HIV, CVA, IHD, CKD. AKI, HBSAg, Pulmonary TB. Pneumonia, Bronchial asthama, Pleurisy or any other major disease..
2.Patient not willing to partcipate in the study
3. Pregnant I lactating mothers
4. Patients below 18 yrs and above 60 yrs age |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like ..
1) Shushka Kasa vega
2) Hritshool
3) Parshwashool
4)Shirshool
5) Shushka Vaktra
6)Swarbhed |
5 Days ,10 days,15 days and 20 days after starting treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreasing symptoms of vataj Kasa |
18 month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/03/2025 |
| 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 Yet Recruiting |
| 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
|
As it is indicated in Ayurveda, body is Stroatas (channels) and the disturban Ahar Vihara (diet and activities) and environmental pollution leads to Strotodush (vitiation of channel) especially Pranvaha Strotas and Sang (obstruction).Strotodu causes vitiation of different Doshas in the body. In ayurveda there is description of kasa as a symptom as well as independe vyadhi with its own pathology, signs and symptoms and various types of treatme The ayurvedic physician "Aacharya Charak" recognised the disease Kasa 2000 yea ago and he stated the proper line of treatment in Chikitsasthan. There are 5 types of Vayu i.e Prana, Udana, Apana, Vyana and Samana. Amo this types of vayu Prana vayu is most important vayu because it is related with lif all types of age group respiratory infection are very common which spread throu air by droplet infection. Ayurveda has a vast quality of drugs to cure the diseasekasa as well as it provides preventive measure for such disease. The lakshna of Kasa are Shushka Kasa vega, Ura parshwa pida, Shirshool, Shushka Vaktra, Swarabhed etc. Clinical features of kasa are mainly cough, irritation of throat, pain in throat, difficulty in swallowing. Shodhan chikitsa and shaman chikitsa are basic principle for treatment of Kasa mentioned by Aacharya Charak. Shaman chikitsa is more easier type of treatment in the management of kasa. As Pranavaha Strotas conveys Prana, any disease affecting this Strotas has to be treated with priority. Vataja Kasa is not life threatening, but it is becoming progressively uncomfortable and inconvenient for individual in his daily activities. In recent years, there has been a remarkable increase in incidence related with the respiratory system due to exposure to both active passive smoke, air pollution, and occupational dangers. The prevalence of the disease is reported approximately 10 - 20% of general population. In modern science limited and temporary treatment options are available like cough syrup and steroids etc. In Ayurveda plenty of drugs and their many kalpanas are available and are effective in the management of vataj kasa. There hasn’t been a study comparing Dusparshadi Leha and Duralabhadi Leha the management of Vataj Kasa yet. To re-evaluate its efficacy in treatment of Vataj Kasa so this topic has been selected. The main moto of study is to provide an Ayurvedic treatment modality with minimal side effects as compared to modern treatment. |