| CTRI Number |
CTRI/2024/11/076196 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the efficacy of Devadarubaladi Taila Nasya in the management of Avabahuka(Frozen Shoulder). |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Devadarubaladi Taila Nasya in the management of Avabahuka(Frozen Shoulder). |
| 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 Dikshanti Suresh Matre |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD No 15 C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9503430297 |
| Fax |
|
| Email |
dikshantimatre2917@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Dnyanoba Sonwane |
| Designation |
Professor |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD No 15 C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9579773404 |
| Fax |
|
| Email |
ramesh10673@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dikshanti Suresh Matre |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9503430297 |
| Fax |
|
| Email |
dikshantimatre2917@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S. Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
| Address |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan Road, Aurangabad,
Maharashtra India 431011
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Dikshanti Suresh Matre |
C.S.S.M.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi |
OPD No 15 Panchakarma Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA |
9503430297
dikshantimatre2917@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Aurangabad |
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 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtang Hrudaya Sutra Sthan 20, Procedure details: The patient will be asked to lie down over droni in supine position with head low & tip of nose facing towards the roof. Nasya medicine will be warmed by keeping it in warm vessel. Patients eye will be covered with cotton so as to prevent the spilling of taila inside the eyes during instillation. While installing the medicine in one nostril other nostril will kept closed by index finger and thumb. Nasya karma will be done for 7 days. )
(1) Medicine Name: Dashmooladi Taila, Reference: Bhaishajyaratnawali vatvyadhi chikitsa prakaran , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtang Hrudaya sutra sthan 20, Procedure details: The patient will be asked to lie down over droni in supine position with head low & tip of nose facing towards the roof. Nasya medicine will be warmed by keeping it in warm vessel. Patients eye will be covered with cotton so as to prevent the spilling of taila inside the eyes during instillation. While installing the medicine in one nostril other nostril will kept closed by index finger and thumb. Nasya karna will be done for 7 days. )
(1) Medicine Name: Devadarubaladi Nasya , Reference: Sahastrayogyam , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical features of Avabahuka.
Patients above 25 years of age.
Patients will be selected irrespective of sex, religion and economic status.
Nasya Arha. |
|
| ExclusionCriteria |
| Details |
Patients below age group of 25 years.
Nasya anarha.
Patients that having any major systemic disorders, pregnant and lactating mother. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shoulder pain will be decrease.
Range of Motion (ROM) will improve |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Local tenderness will reduce |
7 days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
06/11/2024 |
| 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 Applicable |
| 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
|
Avabahuka is a disease described in ayurvedic literature which is characterized by localized samprapti which affects Ansa Sandhi (shoulder joint) and causs Shoshana (wasting/weaking) of Ansa Bandhanam which leads to Ankuchan of local sira and is produced by the vata associated with kapha dosha. Clinical presentation and pathogenesis of Avabahuka is almost similar to Frozen Shoulder. Frozen shoulder is characterized by painful restriction of both active and passive glenohumeral motion.
In ayurveda, different modalities like Abhyanga, Swedana, Snehapana, Nasya Karma, Basti Karma and Shaman Aushadi are mentioned to combat the vatavyadhi among which nasya plays a vital role in the treatment of avabahuka. The Devadarubaladi taila is vata kapha shamak in nature and it is formulated in tila taila which may produce potent and deeper penetrating action against Avabahuka.
Study wil be conducted on 92 diagnosed patients of Avabahuka(Frozen Shoulder). Written consent will be taken. Initial assessment will be done. patient treated with interventional group Devadarubaladi taila nasya and control group Dashamooladi Taila nasya. Patient will be assessed at follow up. Observation and result will be noted and statistical analyasis, Discussion and conclusion will be done.
Null Hypothesis (Ho) - Devadarubaladi Taila Nasya is not effective in the management of Avabahuka( Frozen Shoulder). Alternate Hypothesis(H1) - Devadarubaladi Taila Nasya is effective in the management of Avabahuka ( Frozen Shoulder) |