CTRI/2023/03/051189 [Registered on: 29/03/2023] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Efficacy of Ayurvedic Management in Spastic Cerebral Palsy
Scientific Title of Study
Efficacy of Ayurveda treatment protocol with and without Salavana Upanaha Sweda in the management of Spastic Cerebral Palsy – An open labelled randomized comparative clinical trial
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Manju
Designation
MD Scholar
Affiliation
Institute of Teaching and Research in Ayurveda, Jamnagar
Address
Department of kaumarbhritya, 5th floor, Institute Building, Institute of Teaching and Research in Ayurveda, Opposite B- Division Police Station, Gurudwara Road, Jamnagar
Jamnagar GUJARAT 361008 India
Phone
9588105688
Fax
Email
anjurana1530@gmail.com
Details of Contact Person Scientific Query
Name
Dr V K Kori
Designation
Assistant Professor
Affiliation
Institute of Teaching and Research in Ayurveda, Jamnagar
Address
Department of kaumarbhritya, 5th floor, Institute Building, Institute of Teaching and Research in Ayurveda, Opposite B- Division Police Station, Gurudwara Road, Jamnagar
Jamnagar GUJARAT 361008 India
Phone
9374548475
Fax
Email
drvkkori@yahoo.co.in
Details of Contact Person Public Query
Name
Dr V K Kori
Designation
Assistant Professor
Affiliation
Institute of Teaching and Research in Ayurveda, Jamnagar
Address
Department of kaumarbhritya, 5th floor, Institute Building, Institute of Teaching and Research in Ayurveda, Opposite B- Division Police Station, Gurudwara Road, Jamnagar
Jamnagar GUJARAT 361008 India
Phone
9374548475
Fax
Email
drvkkori@yahoo.co.in
Source of Monetary or Material Support
Dept. of Kaumarbhritya, 5th floor, Institute Building, ITRA, Jamnagar
(1) Medicine Name: Shunthi Churna, Reference: Bhavprakash Nighantu- Haritakyadi Varga – Sloka no. 44, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: In both groups, Deepana – Pachana will be given for 3 days with Shunthi Churna before initiation of first course.
2
Intervention Arm
Procedure
-
udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥
(Procedure Reference: Astanga Hridya, Sutra sathan 2/14, Pg. 26 , Procedure details: Udvartana: With Yava and Kulattha Churna in the same proportion will be done for 3 days. )
3
Intervention Arm
Procedure
-
aBya~ggaH, अà¤à¥à¤¯à¤‚गÂ
(Procedure Reference: Ch. Chi. 28/ 81, Pg. 791, Procedure details: Abhyanga with Bala Taila will be done for 20 min. followed by Nadi Swedana for 7 days.)
4
Intervention Arm
Procedure
-
nADIsvedaH, नाडीसà¥à¤µà¥‡à¤¦à¤ƒ
(Procedure Reference: Ch. Chi. 28/78, Pg. 791, Procedure details: Abhyanga with Bala Taila will be done for 20 min. followed by Nadi Swedana for 7 days.)
5
Intervention Arm
Procedure
-
pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶
(Procedure Reference: Astanga Hridya, Sutra Sathan 20/1, Pg.172 Ch. Siddhi 8/116-117, Procedure details: Purva Karma - Advice the patient to lie down on Nasya table. Mrudu Abhyanga should be done on scalp, forehead, face, and neck for 5-10 minutes by medicated oil like Bala Taila followed by mild Swedana (Sudation). According to Ayurvedic classics Swedana should not be given to the head.
Pradhana karma- The patient should be lie down in supine position and head should be “Pralambita†i.e hanging down slightly .Then, raise the tip of the patients nose with his left thumb, and with the right han) (1) Medicine Name: Astanga Ghrita, Reference: Astanga Hridya, Uttar Tantra 1/43-44, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 7 Days
(Procedure Reference: Salavana Upanaha Sweda- Astanga Hridya, Sutra Sathan 17/3,, Procedure details: Quantity sufficient of the mixture of Godhumadi Churna will be taken.
Thickness of Lepa: Q.S.
Duration: For 6 to 8 Hours.
Mode of Administration:
Purva Karma: Sarvanga Abhyanga will be done with Bala Taila for a period of 20 minutes followed by Ushana jala snana.
Pradhana Karma:
• This paste will be applied to the afflicted limb in Pratiloma Gati at a temperature that would not cause burns in the child forming the first layer in contact with the skin.
• The next step is application )
(Procedure Reference: Astanga Hridya, Sutra sathan 2/14, Pg. 26, Procedure details: Udvartana: With Yava and Kulattha Churna in the same proportion will be done for 3 days.)
11
Comparator Arm
Procedure
-
saravA~gga, सरà¥à¤µà¤¾à¤‚गÂ
(Procedure Reference: Ch. Chi. 28/ 81, Pg. 791, Procedure details: Abhyanga with Bala Taila will be done for 20 min. followed by Nadi Swedana for 7 days)
12
Comparator Arm
Procedure
-
nADIsvedaH, नाडीसà¥à¤µà¥‡à¤¦à¤ƒ
(Procedure Reference: Ch. Chi. 28/78, Pg. 791, Procedure details: Abhyanga with Bala Taila will be done for 20 min. followed by Nadi Swedana for 7 days.)
13
Comparator Arm
Procedure
-
pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶
(Procedure Reference: Astanga Hridya, Sutra Sathan 20/1, Pg.172 Ch. Siddhi 8/116-117, Procedure details: Purva Karma - Advice the patient to lie down on Nasya table. Mrudu Abhyanga should be done on scalp, forehead, face, and neck for 5-10 minutes by medicated oil like Bala Taila followed by mild Swedana (Sudation). According to Ayurvedic classics Swedana should not be given to the head.
Pradhana karma- The patient should be lie down in supine position and head should be “Pralambita†i.e hanging down slightly .Then, raise the tip of the patients nose with his left thumb, and with the right han) (1) Medicine Name: Astanga Ghrita, Reference: Astanga Hridya, Uttar Tantra 1/43-44, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 7 Days
Children of Spastic Cerebral Palsy with developmental disability either physical or mental in mild or moderate degree as compared to normal children
ExclusionCriteria
Details
Children of Ataxic, Athetoid and Dyskinetic CP with major congenital disorders, chromosomal disorders and other disease status viz. Juvenile DM, CHD.
Patients with acute infections.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in Muscle spasticity checked via Modified Ashworth scale (MAS) and contracture by goniometry.
Change in gross motor function by GMFCS E&R.
Improvement in ADL (Activity of Daily Living) scale.
On day 0 and after 83 days
Secondary Outcome
Outcome
TimePoints
Improvement in Muscle power checked via MRC scale. (BT and AT)
On day 0 and after 83 days
Target Sample Size
Total Sample Size="20" Sample Size from India="20" 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 3
Date of First Enrollment (India)
25/04/2023
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Not yet Published
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Introduction: Among various neurodevelopmental disorders, Cerebral palsy is the commonest chronic motor disability that affects childhood. It is the diagnostic term used to describe a group of permanent disorders of movement and posture causing activity limitation that are attributed to nonprogressive disturbances in the developing fetal or infant brain.
Significance:As cerebral palsy is an umbrella term, a single therapy can not cure this. In this condition, Ayurvedic protocol of management can enhance the quality of life of the suffering child. It has been proved in earlier studies that Panchakarma therapy has a great role in the management of spastic CP. Hence the prime goal of the study is to find out the complete treatment protocol that can reduce spasticity, contracture, rigidity, disabilities and thereby providing maximum quality of life.
Aim and Objectives : To evaluate and compare the efficacy of Ayurveda treatment protocol (Deepana-Pachana, Udvartana, Abhyanga-Swedana, Astanga Ghrita Pratimarsha Nasya, Chaturbhadra Kalpa Basti and Medhya Churna orally) along with and without Salavana Upanaha Sweda in the management of Spastic Cerebral Palsy.
Material and methods: The present study is an open labelled randomized comparative clinical trial on Spastic Cerebral Palsy in children of either sex between 1 year to 10 years of age.
20 pre-diagnosed and newly diagnosed patients of spastic cerebral palsy will be enrolled in two groups with 10 patients in each group.
For that, Group A is provided with Ayurveda Treatment Protocol (Deepana-Pachana, Udvartana, Abhyanga-Swedana, Astanga Ghrita Pratimarsha Nasya, Chaturbhadra Kalpa Basti and Medhya Churna orally) along with Salavana Upanaha Sweda,
while Group B is given Ayurveda Treatment Protocol (Deepana-Pachana, Udvartana, Abhyanga-Swedana, Astanga Ghrita Pratimarsha Nasya, Chaturbhadra Kalpa Basti and Medhya Churna orally) without Salavana Upanaha Sweda.
The total duration of study is 83 days and follow up of 30 days will be carried out.
Results and Discussion: Data generated during the above study will be presented in a systemic manner and shall be analyzed statistically. Follow up: After completion of therapy, follow up will be done for 1 month to assess the status of patient, where the patient will be asked to report.
Adverse effects: This proposal will be reviewed and approved by ITRA, Institutional Ethics Committee, which is having the responsibility to protect the research participants from harm. These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse drug reactions if any observed will be reported to the Pharmacovigilance cell of ITRA.