| CTRI Number |
CTRI/2025/02/080541 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare effectiveness of Nasya Karma and snehapan with swalapamasha taila along with Sthanik abhyanga and Adtiya paka guggulu (Orally) in cases of avabahuk(WSR to Frozen Shoulder) |
|
Scientific Title of Study
|
A clinical study to compare effectiveness of Nasya Karma and snehapan with swalapamasha taila along with Sthanik abhyanga and Adtiya paka guggulu (Orally) in cases of avabahuk(WSR to 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 Kamal Kishor |
| Designation |
MD SCHOLAR |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa, State Ayurvedic College
and Hospital, Lucknow 226004 Tulsidas Marg, Tudiyaganj, Lucknow
Lucknow
UTTAR PRADESH
226004
India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8299083292 |
| Fax |
|
| Email |
kamal43727@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurmeet Ram |
| Designation |
READER |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa, State Ayurvedic College
and Hospital, Lucknow 226004 Tulsidas Marg, Tudiyaganj, Lucknow
Lucknow
UTTAR PRADESH
226004
India
State Ayurvedic College and Hospital, 226004 Tulsidas Marg, Tudiyaganj, Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9412360556 |
| Fax |
|
| Email |
Gurmeet.dr70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Kishor |
| Designation |
MD SCHOLAR |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa, State Ayurvedic College
and Hospital, Lucknow 226004 Tulsidas Marg, Tudiyaganj, Lucknow
Lucknow
UTTAR PRADESH
226004
India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8299083292 |
| Fax |
|
| Email |
kamal43727@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Lucknow 226004 Tulsidas Marg, Tudiyaganj,Lucknow, UTTAR PRADESH, 226004, India |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
State Ayurvedic College and Hospital, Lucknow 226004 Tulsidas
Marg, Tudiyaganj, Lucknow UTTAR PRADESH 226004 India |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kamal Kishor |
State Ayurvedic college and hospital Lucknow |
Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital Ground floor Room No 25, Lucknow 226004 Tulsidas Marg, Tudiyaganj, Lucknow
UTTAR PRADESH, 226004
INDIA
Lucknow
UTTAR PRADESH |
8299083292
kamal43727@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee state ayurvedic college and hospital lucknow |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AVABAHUKAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Astang Hrudaya Sutra 19/01, Procedure details: Preparation (Purvakarma):The patient avoids heavy meals & undergoes Abhyanga (oil massage) on the neck, shoulders, & face using warm medicated oil (swalp masha tail) for 05-10 minutes.
Mild Swedana (steam therapy) is given to open the channels.
Main Procedure (Pradhana Karma):The patient lies supine with the head tilted back.6 drops of medicated oil (Swalapamasha Taila) are instilled into each nostril while the patient inhales deeply.Gentle massage around the nose and neck follows.
Post-Procedure (Paschatkarma):
The patient gargles with warm water and rests for 15–20 minutes.
Avoid cold exposure and consume light, warm food.)
(1) Medicine Name: Swalpa masha taila, Reference: CHAKRADUTTA SAMHITA CHIKITSA STHANA 28/55, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Adtiyapaka Guggulu, Reference: Vanga Samhita Vata Vyadhi Chikitsa 214-216, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of the age group between 25-65 years will be selected.
2. Sex: Both male & female.
3. All socioeconomically persons.
4. Patient voluntarily willing to participate in the trial. |
|
| ExclusionCriteria |
| Details |
1. Patients below age of 25 years and above 65 years of age.
2. Patients not fit for treatment.
3. Patients having injury to Shoulder Joint.
4. Diabetic Neuropathy.
5. Gouty & Rheumatoid arthritis.
6. Any other Systemic Disorder. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE CRITERIA
Essential Criteria
1. Bahu Shoola(Shoulder Pain)
Non-Essential criteria:
1. Stiffness of Shoulder.
2. Wasting of Shoulder
3. lack of the movement of Shoulder
4.Radiation of pain to back of head & arms
5. Sleep Disturbance
6. Paresthesia |
before trial,15days , 30days,45days,60days,
after one month of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OBJECTIVE CRITERIA
1. Ant. Elevation of Shoulder Joint
2. Int. Rotation of Shoulder Joint
3. Ext. Rotation of Shoulder Joint |
before trial,15days , 30days,45days,60days,
after one month of trial |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/02/2025 |
| 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
|
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Brief Summary
|
AIM & OBJECTIVES: 1. To assess the effectiveness of trial drug in improving the condition of disease. 2.To assess the effectiveness of trial drug (Svalpmasha Tail & Adityapak Gugglu) in improving quality of life in patients of Avabahuka w.s.r Frozen Shoulder. 3. To compare the efficacy of Svalp Masha Tail when used Externally (Abhyanga) & Internally (Nasya & Snehpan) & sanshamana chikitsa by Adityapak Guggul for internal administration in patients of Avabahuka w.s.r Frozen Shoulder. 4. To observe clinical improvement/ prognosis/ recurrence of disease during the follow up period. PLAN OF STUDY Selection of cases: For the purpose of clinical trial, the patient of Avabahuka w.s.r Frozen Shoulder will be selected from OPD and IPD of ‘State Ayurvedic College and Hospital, Lucknow’ and other hospitals who will fulfil the criteria of selection of patients irrespective of their sex, caste and religion. A careful history, physical examination and necessary investigations will be performed as per Performa prepared for the present trial. INCLUSION CRITERIA: 1. Patient of the age group between 25-65 years will be selected. 2. Sex: Both male & female. 3. All socioeconomically persons. 4. Patient voluntarily willing to participate in the trial. Symptoms- According to Astang Hridaya Ni. 15/43 Type of study: Phase 2, Rational, Randomized parallel group study. • Period of study- Total duration of clinical trial is 3 months. Follow up period- During the treatment - 15 Days. After the treatment - 15 Days. Sample Size: Minimum 50 patients of Avabahuka w.s.r Frozen Shoulder from OPD and IPD of State Ayurvedic College and Hospital and referred cases of other hospital will be selected and randomly divided in two group i.e., group A and group B with approximately 10% drop out. Grouping: Group A- In this group patient will be treated with Nasya (internal use of Svalp Masha tail) & Sthanik Abhyanga along with Adityapak Gugglu orally for 15 Days. Group B- In this group patient will be treated Snehpan (internal use of Masha tail) & Sthanik Abhyanga along with Adityapak Gugglu (orally) for 15 Days. PLAN OF TREATMENT Group A: In this group of patients, Nasya (Marsha Nasya) will be given with Svalpmasha Tail in each nostril 6 Drops & Sthanik Abhyanga on shoulder region to neck region for 15 min. in Evening & Adityapak guggul orally 2-tab (each tab. 500 mg) B.D. with lukewarm water after taking meal. Group B: In this group of patients, Snehpana of Svalpmasha Tailam (30 M.l., B.D. with milk) will be given & Sthanik Abhyanga on shoulder and neck region for 15 min. in Evening along with Adityapak guggul orally 2-tab (each tab. 500 mg) B.D. with lukewarm water after taking meal. |