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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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 | 2 | Comparator Arm | Drug | Classical | | (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 | 3 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (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 | 4 | Comparator Arm | Drug | Classical | | (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 |
|
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. |