| CTRI Number |
CTRI/2025/09/094744 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the efficacy of Adityapaka Guggulu and Trayodashanga Guggulu along with Nasal therapy in the management of Frozen Shoulder |
|
Scientific Title of Study
|
A Randomised Double Arm Comparative Clinical study to evaluate the efficacy of Adityapaka Guggulu and Trayodashanga Guggulu along with Nasya karma in the management of Avabahuka vis a vis Frozen Shoulder |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha K |
| Designation |
PG Scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital,Hubballi |
| Address |
PG Scholar,Department of Kayachikitsa,OPD NO.1,Ayurveda Mahavidyalaya and Hospital,Heggeri Extension,Old Hubli-580024
Dharwad
KARNATAKA
580024
India |
| Phone |
8073990924 |
| Fax |
|
| Email |
snehaskl123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivaji Chavan |
| Designation |
HOD and Professor |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital,Hubballi |
| Address |
HOD and Professor,Department of Kayachikitsa,Ayurveda Mahavidyalaya and Hospital,Heggeri extension,Old Hubli-580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9448335479 |
| Fax |
|
| Email |
shivajichavan1671@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha K |
| Designation |
PG Scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital,Hubballi |
| Address |
PG Scholar,Department Of Kayachikitsa,OPD NO.1 Ayurveda Mahavidyalaya and Hospital,Heggeri Extension, Old Hubli,580024
Dharwad
KARNATAKA
580024
India |
| Phone |
8073990924 |
| Fax |
|
| Email |
snehaskl123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya and Hospital,Heggeri Extension,Old Hubli-580024 |
|
|
Primary Sponsor
|
| Name |
Dr Sneha K |
| Address |
Ayurveda Mahavidyalaya and Hospital,Heggeri extension,Old Hubli-580024 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SELF |
Ayurveda Mahavidyalaya and Hospital,Hubballi. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSnehaK |
Ayurveda Mahavidyalaya and Hospital Hubli |
Ayurveda Mahavidyalaya And Hospital Heggeri extension OldHubli 580024
Dharwad
KARNATAKA |
8073990924
snehaskl123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Clearance Certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M248||Other specific joint derangements,not elsewhere classified. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Adityapaka Guggulu, Reference: Chikitsa Sara Samgraha of Vangasena, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashanga Guggulu, Reference: Chikitsa Sara Samgraha of Vangasena, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with the clinical features of Avabahuka Frozen Shoulder
Subjects of both the gender age in between 40 to 60 years
Subjects with chronicity of the disease from 4 months to1 year Frozen Stage |
|
| ExclusionCriteria |
| Details |
Subjects with Rheumatoid Arthritis Tubercular Arthritis Systemic Lupus Erythematous
Psoriatic Arthritis Gouty Arthritis and Osteoarthritis of Shoulder joint
Subjects with fracture and dislocation of Shoulder joint
Subjects with Uncontrolled metabolic disorders like Diabetes mellitus Hypertension and
Thyroid disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced Restricted Range of Movements in Affected Shoulder Joint |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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 Yet Recruiting |
| 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 explained under Vatavyadhi in Brihatrayi as well as Laghutrayi. Acharya Sharangadhara and Bhavamishra included it under 80 types of Vataja Nanatmaja Vyadhi Further continuously indulging in Vata Prakopaka Aahara and Vihara leads to Sthanasamshraya of Prakupita Vata in Khavaigunyayuktha Sandhi here Amsa Sandhi where Dravataha Kshaya of Shleshaka Kapha occurs leading to Amsa Shosha Amsabandhana Shosha and Sonkochana of Mamsa Peshi Sira and Snayu This Dhatu Kshayajanyayukta Avabahuka will leads to Bahu Shula and Bahu Praspanditahara In Avabahuka Amsa Sandhi is involved which is the seat of Amsa Marma and any injury to this Marma will leads to Bahu Sthabdata The Clinical presentations of Avabahuka can be compared to Adhesive Capsulitis which is commonly referred to as Frozen Shoulder and characterized by an insidious painful inflammatory condition of the Shoulder Girdle which is accompanied by gradual progressive stiffness and significant restriction of both active and passive range of motion Peak incidence of Frozen Shoulder is more commonly seen in Women and Manual workers of age 40 to 60 years In Allied science various treatment modalities are available such as Analgesics NSAIDs Physiotherapy and Arthroscopic Surgery etc yet satisfactory results are not observed Hence here an attempt will be made to treat such individuals suffering from Frozen Shoulder using the treatment modalities of Ayurveda such as Ama Pachana Nasya Karma and Shamanoushadis For Ama Pachanartha Ajamoda Churna is opted which has Katu Rasa Laghu Ushna Teekshna and Krimihara Properties does Ama Pachana Agni Sandeepana and Vatanulomana For Nasya Karmartha Mahamasha Taila has been selected which does Brihmana and possesses Madhura Rasa Snigdha Guna and Vatahara Properties that will nourishes the Dhatu For Shamanartha Adityapaka Guggulu and Trayodashanga Guggulu has been selected in which both are mentioned under Vatavyadhi Prakarana by Acharya Vangasena in the treatise called Chikitsa Sara Sangraha |