Drakshadi yoga in the management of Kaphaja Kasa
- Conditions
- Patients of either sex aged between of 5 to 10 years Patients with classical Kaphaja Kasa lakshana(pinasa, aruchi, chardi)
- Registration Number
- CTRI/2018/02/012160
- Lead Sponsor
- KAHER Shri B M K Ayurveda Mahavidyalaya
- Brief Summary
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF DRAKSHADI LEHA IN THE MANAGEMENT OF KAPHAJA KASA IN CHILDREN
**NEED FOR THE STUDY:**
Respiratory system is in continuous contact with the external environment since birth up till death. So respiratory tract infection account for more than 50% of the patients attending the paediatric OPD. Among the major causes of consultation at Primary Health Care Center the study has been carried by Pediatric Dept. among which 71.1% respiratory complaint [1]. Recurrent attack of cough shows a prevalence rate of 1.06%. Among them the maximum number of cases of the study were seen in the age of 5 to 10 years [2]. Some of the common side effects of practicing modern medicines in the management of cough are tremor, nervousness, headache, dizziness, hyperactivity, sleeplessness etc.
Kaphaja Kasa has been mentioned as one among five types of Kasa. It is the most commonest complaints in day to day practice and it is also a symptom of many diseases of respiratory system. [5]. Complaints of Kaphaja kasa are Aruchi , Chardi , Pinasa..etc[3] To treat these complaints , Drakshadi yoga(leha) has been selected which contains drugs like Draksha[4], Pippali[4] and Shunthi[4]. They possess kaphahara, kasaahara and deepana properties.
As per our hypothesis this leha may help more in clearing up productive cough present in Kaphaja kasa and reduce the symptoms. This leha can be easily palatable and cost effective to be administered in children
**REVIEW OF LITERATURE:**
Ayurvedic classics have advised various formulations in the management of Kaphaja kasa. Kasa description regarding nidana, samprapti, poorvaroopa, bheda, lakshana, upashaya, anupashaya, upadrava and chikitsa from the Charaka Samhitha Chikitsasthana kasa chikitsa[3], sushrutha samhitha uttaratantra [5] and Kashyapa Samhitha in the context of Uroghata rog[6]
Cough is the protective reflex, its purpose being expulsion of respiratory secretions or foreign particles from air passages. Cough will also be reviewed from Modern Medical Texts.
The references of Drakhsadi yoga[7] and Talisadi churna[8][9] will be reviewed from Bhaishajya Ranatakar and Bhaishajya Ratnavali and Sharangdhara Samhita Madhyama Khanda 6/132. The drugs present in the yoga and churna will be reviewed from different Nighantu and Samhitas
**PREVIOUS RESEARCH WORK**
1. Dr.Praveen Mugabasav“Efficacy Of Duralabadi Leha V/S Talisadi Churna In The Treatment Of Kaphaja Kasa-A Randomized Comparative Clinical Study†Shri B.M.K Ayurveda Mahavidhyalaya Belgavi)
2. Dr.Anantamati N.Bammagol“Evaluation Of The Efficacy Of Ativishadi Yoga As An Antitussive Drug –A Randomised Control Clinical Trial†(Shri B.M.K Ayurveda Mahavidhyalaya Belgavi)
**OBJECTIVE OF THE STUDY:**
**Primary**
- To evaluate the efficacy of Drakshadi Leha in Kaphaja Kasa in children
**Secondary**
- To compare the effect of Drakshadi Leha over Talisadi Churna in Kaphaja Kasa in children
**RESEARCH QUESTION**
- Is Drakshadi Leha effective in Kaphaja Kasa of 5 to 10 years children?
**HYPOTHESIS:**
**H0**
- There will be no effect of Drakshadi Leha over Talisadi churna at the age of 5 to 10 years in Kaphaja Kasa
**H1**
- There will be effect of Drakshadi Leha over Talisadi churna at the age of 5 to 10 years in Kaphaja Kasa
**RESEARCH DRUG**
- **Drakshadi yoga**
| | | | | | |
| --- | --- | --- | --- | --- | --- |
|**Drugs**
**Rasa**
**Veerya**
**Vipak**
**Guna**
**Karma**
|Draksha
Madhura
sheeta
Madhura
Guru Snigdha
Kasahara
|Pippali
Katu
Anushna Sheeta
Madhura
Laghu Snigdha Tiksna
Kasahara
|Shunthi
Katu
Ushna
Madhura
Laghu Snigdha
Deepan
**TABLE OF DRUG REVIEW (Drakshadi yoga)**
| | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
|**SANSKRIT NAME**
**LATIN NAME**
**FAMILY**
**OFFICIAL PART**
**PRAPORTION**
**COLLECTION METHOD**
|Draksha
*Vitis*
*vinifera*
Linn.
Vitaceae
Phala
1 part
GMP certified pharmacy
|Pippali
*Piper*
*longum*
Linn.
Piperaceae
Phala
1 part
GMP certified pharmacy
|Shunthi
*Zinger*
*officinale*
Rosc.
Zingiberaceae
Shushkakand
1 part
GMP certified pharmacy
**PACKAGING AND STORAGE**
Packaging from GMP Certified Ayurveda Pharmacy and storage from MRC
**Drug Preparation Method**
Drakshadi yoga will be prepared as per Standard Operative Procedures double quantity of the honey will be added for preparation of Drakshadi leha
**Analysis:** Drakshadi Leha & Talisadi churna will be analysed as per the API standard in K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya pharmacy, Shahapur, Belagavi
**STUDY TYPE**
Interventional
**STUDY DESIGN**
Prospective
**MASKING**
Open label
**CONTROL**
Controlled
**END POINT**
Efficacy
**Multiple Groups**
| | |
| --- | --- |
|Group Name
Description
|GROUP-A
15
|GROUP-B
15
**Total Number of Subjects**
30
**DIAGNOSTIC CRITERIA**
The diagnosis is mainly based on lakshanas of Kaphaja kasa as described in Ayurvedic classics
- Kasa
- Aruchi
- Chardi
- Peenasa
- Shira shoola
**INCLUSION CRITERIA**
- Patients of either sex aged between of 5 to 10 years
- Patients with classical Kaphaja Kasa lakshana(pinasa, aruchi, chardi)
**EXCLUSION CRITERIA**
- Patients below age group of 5 year and above 10 year
- Lobar pneumonia
- Known case of T.B, COPD
- All types of Kasa except Kaphaja kasa lakshan will be excluded
- Other systemic illness necessitating treatment other than for co
**GROUPS & INTERVENTION INCLUDING FOLLOW UP:**
| | | | | |
| --- | --- | --- | --- | --- |
|**NAME OF THE GROUP**
**SAMPLE SIZE**
**INTERVENTION WITH DOSE**
**DURATION**
**FOLLOW UP**
|GROUP-A
15
Drakshadi leha ,
Doses in gms TDS 5yr-5gms/day , 6yr-6gms/day , 7yr-7gms/day ,
8yr-8gms/day ,9yr-9gms/day ,
10yr-10gms/day
5 days
1st- 5th day, 2nd-10th day
|GROUP-B
15
Talisadi churna,
Doses in gms TDS 5yr-5gms/day , 6yr-6gms/day , 7yr-7gms/day ,
8yr-8gms/day ,9yr-9gms/day ,
10yr-10gms/day
5 days
1st- 5th day, 2nd-10th day
**SOP**
All the raw drugs required for the preparation for Drakshadi yoga are to be made into churna separately and mix them homogeneously in equal quantity to prepare Drakshadi yoga and add double quantity of honey to prepare Drakshadi leha
**ASSESSMENT CRITERIA**
**OBJECTIVE PARAMETERS**
**Added sounds**
1. Wheeze[12]
- Marked poly2phonic wheezing all over the lung field - Grade 04
- Polyphonic moderate wheezing all over the lung field - Grade 03
- Marked polyphonic wheezing limited to zones - Grade 02
- Mild monophonic wheeze present - Grade 01
- Wheezing absent - Grade 00
2. Crepitation[12]
- Scattered all over the lungs field - Grade 03
- Distributed here and there in all the zones - Grade 02
- Present in one or two zones - Grade 01
- Absent crepitation - Grade 00
3. Sputum[12]
- Thick large quantity of solid white/yellow /Green sputum - Grade 03
- Moderately thick slightly white in color - Grade 02
- Serous expectoration with traces of thick sputum - Grade 01
- No productive cough - Grade 00
**SUBJECTIVE PARAMETERS**
Classical symptom of Kaphaja kasa like
1. Peenasa(nasal discharge)[10]
- Yellowish nasal discharge with large quantity with headache - Grade 03
- Yellowish nasal discharge with heaviness of head - Grade 02
- Nasal discharge in less quantity - Grade 01
- No nasal discharge - Grade 00
2. Chardi(vomiting)[11]
- More than 4 episodes - Grade 03
- 2-4 episodes - Grade 02
- 1-2 episodes - Grade 01
- Absent of vomiting - Grade 00
3. Aruchi(loss of appetite)[11]
- Patient avoid food - Grade 03
- Sometimes takes food properly, most of time avoid - Grade 02
- Less oral intake compare to routine diet - Grade 01
- Take normal diet - Grade 00
4. Number of bouts of cough[12]
The number of bouts of cough in one hour were noted in each patient and graded as follow
- More than 8 bouts of cough - Grade 03
- 3 to 7 bouts of cough - Grade 02
- Less than 3 bouts of cough - Grade 01
- Absence of bout of cough - Grade 00
5. Duration of bouts of cough[12]
The duration of each bout of cough in seconds is observed and the duration of 15 such bouts is counted and mean time of cough is calculated-
- Duration of cough more than 15 seconds - Grade 04
- Duration of cough 10-15 seconds - Grade 03
- Duration of cough in between 5-9 seconds - Grade 02
- Duration of cough less than 5 seconds - Grade 01
- Absence of cough - Grade 00
6. Disturbance of sleep[12]
- Cough always disturbs sleep - Grade 03
- Gets cough before sleeping or wakes children in the morning - Grade 02
- Cough occasionally disturbs sleep - Grade 01
- Doesn’t interfere with sleep - Grade 00
**FREQUENCY OF ASSESSMENT**
2 times
**STATISTICAL METHODS TO ANALYSE THE DATA**
Man whitney U test
**EXPECTED OUTCOMES**
- Drakshadi leha would help in the management of Kaphaja Kasa in children more efficiently than Talisadi churna.
**WITHDRAWAL CRITERIA**
- During the course of the study if patient develops any untoward effect then the patient will be withdrawn from the study
**RESCUE MEDICATION**
In case of any condition suggestive of possible deterioration of health appropriate measure will be taken like facilitation in consulting the specialist of the concerned field
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
Patients of either sex aged between of 5 to 10 years Patients with classical Kaphaja Kasa lakshana(pinasa, aruchi, chardi).
Patients below age group of 5 year and above 10 year Lobar pneumonia Known case of T.B, COPD All types of Kasa except Kaphaja kasa lakshan will be excluded Other systemic illness necessitating treatment other than for co.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drakshadi yoga would help in the management of Kaphaja Kasa in children more efficiently than Talisadi churna. 5days intervention | 1st followup-5th day | 2nd followup- 10th day
- Secondary Outcome Measures
Name Time Method the effect of Drakshadi leha over Talisadi Churna in Kaphaja Kasa in children will be more effective 5days intervention
Trial Locations
- Locations (1)
KAHER Shri B M K Ayurveda Mahavidyalaya
🇮🇳Belgaum, KARNATAKA, India
KAHER Shri B M K Ayurveda Mahavidyalaya🇮🇳Belgaum, KARNATAKA, IndiaDr Pranoti A ManePrincipal investigator8904844921pranotimane06@gmail.com