FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/02/050049 [Registered on: 24/02/2023] Trial Registered Prospectively
Last Modified On: 23/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A comparative clinical study of prasarinyadi kashaya and karpasasthyadi tail in the management of frozen shoulder  
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of prasarinyadi kashaya and karpasasthyadi tail in avabahuka vyadhi wsr to frozen shoulder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrDipika dhruw 
Designation  PG Scholar Department of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur  
Address  OPD Number 2 and 18, Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurved College Raipur

Raipur
CHHATTISGARH
492010
India 
Phone  8319083088  
Fax    
Email  dipidhruw@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRashmi Diwan 
Designation  Lecturer in Department of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur  
Address  Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurved College Raipur

Raipur
CHHATTISGARH
492010
India 
Phone  9770933579  
Fax    
Email  rashmi.diwan3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrAruna Ojha 
Designation  Proffesor in Deparment of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur  
Address  Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurved College Raipur

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 
 
Primary Sponsor  
Name  Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurved College Raipur CHHATTISGARH 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 
Type of Sponsor  Other [Government Ayurved College Raipur ] 
 
Details of Secondary Sponsor  
Name  Address 
Shri Narayan Prasad Awasthi Govt Ayurved College Raipur CHHATTISGARH  Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrDipika Dhruw  Shri Narayan Prasad Awasthi Government Ayurved College Raipur CHHATTISGARH  OPD Number 2 and 18, Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurved College Raipur
Raipur
CHHATTISGARH 
8319083088

dipidhruw@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Prasarinyadi kashaya, Reference: sahastra yoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: jaggery), Additional Information: alonge with local appilication of karpasasthyadi tail and nasya 4 drops (each nostril) in evening after meals
2Comparator ArmDrugClassical(1) Medicine Name: prasarinyadi kashaya, Reference: sahastrayoga , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: jaggery), Additional Information: along with abhyang of karpasasthyadi tail
3Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: ashtang hrudaya, Procedure details: 4 drops each nostrils after meals in evening. )
(1) Medicine Name: karpasasthyadi tailam , Reference: sahastra yoga, Route: Nasal, Dosage Form: Taila, Dose: 4(drops), Frequency: od, Duration: 90 Days
4Comparator ArmDrugClassical(1) Medicine Name: karpasasthyadi tail, Reference: sahastrayoga, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 4(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: the gap of nasya is after 15 days in sequence. along with local application of karpasasthyadi tail as abhyang.
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients in the age group of 25-70 years irrespective of gender, caste, religion.
Patients with symptoms described in Ayurveda and modern texts.
pain and stiffness of shoulder joints will be taken as a disease.
Bahupraspandanhar (restriction of movement of shoulder joint) 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduce the symptoms of frozen shoulder especially pain stiffness and restriction of movement of shoulder joint  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
improve the quality of life   90 days 
 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/03/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In Ayurveda, for the maintenance of health, routine, routine, diet, unhealthy diet have been preached. Presently, there has been a lot of change in the life style of human beings in the race of competition, such as sitting in the computer for hours, exercising excessively or improperly, sleeping on strange postures, due to external trauma, etc., pain in the neck and arm is the main symptom. I meet Because of this, the patient starts feeling unable to do the tasks of his daily life. In Ayurveda, this type of pain is called Avabhuk Vyadhi.The disease in which there is no power to do the work of the arm, it is called avabahuk.Vayu ansa located in the root dries up the connections there and produces vein contraction, due to which the function of the arm is affected, it is called avabahuk.The vata dosha living in the root of the shoulder blades compresses the ends there and causes abductor disease. Because of this, all the activities like vibrations of the arms get destroyed.The vata dosha living in the root of the shoulder blades compresses the ends there and causes abductor disease. Because of this, all the activities like vibrations of the arms get destroyed.

Kapha dosha is mainly associated with Vata in Avabahuk, hence use of Vata Kapha killers in its treatment and nasya mention is given due to Urdhva Jatrugat disease.

FROZEN SHOULDER/ ADHESIVE CAPSULITIS

Frozen shoulder is defined as limited function of glenohumeral joint with severe pain and stiffness. Also known adhesive capsulitis as the pathology involves the capsule of the joint which becomes adherent to the humeral head. 

TYPES

1.    PRIMARY – Idiopathic

2.    SECONDARY –Due to shoulder injury surgery,rotator cuff injury,  osteoarthritis,autoimmune disease,thyroid disorders.

 

SYMPTOMS 

1.    Pain

2.    Stiffness

3.    Unable to move shoulder joint

 

At present, about 16-26 percent of the total population is troubled by shoulder pain. Everyday patients of avbahuk are seen in the outpatient department of the hospital.

In modern medical system, symptoms like shoulder pain are found in diseases such as Tiravmad, Jeevansakmat, Dhbhamat, Upbans, Chevadkalaswepe, etc. In the modern system of medicine, many pain-relieving drugs, anti-inflammatory drugs, steroids and finally, entahpbans jatamanjumdaj are advised for the treatment of these diseases, whose effect temporarily gives relief to the patient and long-term use of these drugs can lead to gyapakadamal and Many side effects are also found in Lapj.

Therefore, it is necessary that such a drug should be selected for the dissertation, which can permanently free the patient from the symptoms of the disease and also does not cause side effects of the drug. Therefore, keeping in view the need of easy and effective treatment for the disease, I have selected the nasya and spatial abhyanga of Prasariniyadi Kashay and Karpasasthyadi Taila in Avavahuka disease.

 

the volunteers will be informed about the study protocol. willing participants will be randomly selected as per the coin method. clinical research format will be prepared and validated before the study approval will be taken from the IEC of the NPA government Ayurved college and hospital, Raipur C.G.and CTRI registration will be done. after selection, each participant will be tasted individually and selected according to the selection criteria. Sixty patients of Avabahuka will be selected from Kayachikitsa OPD and IPD Shri NPA government Ayurved college and hospital, Raipur C.G. The case selection was in regards to age, sex, occupation, and socioeconomic conditions. Both acute and chronic phases of Avabahuka patients were taken for the study, following  criteria for diagnosing avabahuka  and  the clinical features of Avabahuka described in ayurveda texts. The present study is a single-center, open-labeled randomized (coin method) comparative clinical trial. A total of 60 clinically diagnosed and registered patients of Avabahuaka were divided randomly by coin method into three groups. Each group will have 20 patients.

Group A: 20 clinically diagnosed patients of Avabahuka will be treated with prasarinyadi kashaya  25 ml two  times in a day  before meal for  90 days along with local application of karpasasthyadi tail as abhyang .

Group B: 20 clinically diagnosed patients of Avabahuka will be treated with prasarinyadi kashaya  25 ml two  times in a day  before meal for  90 days and  4 drops nasya(each nostrils) of karpasasthyadi tail after meal in evening along with local application of karpasasthyadi tail as abhyang .

Group C: 20 clinically diagnosed patients of Avabahuka will be treated with 4 drops nasya (each nostrils) of karpasasthyadi tail after meal in evening along with local application of karpasasthyadi tail as abhyang.

 
Close