| CTRI Number |
CTRI/2026/01/100699 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical trial on the effect of two different intervention in patients of avabahuka w.s.r to Frozen Shoulder |
|
Scientific Title of Study
|
A Comparative Clinical Study on the efficacy of Manjistha guggulu avpidak nasya along with erand nirgundi patrapottali and manjistha guggulu avpidak nasya in the management of avabahuka w.s.r 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 SIVEK GAUTAM |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smruti Ayurved P.G. Mahavidyalay And Chikitsalay Barkhedi Kalan, Bhopal, M.P. |
| Address |
P.G. Department of panchakarma, OPD NO - 5, Rani Dullaiya Smriti Ayurved PG College and Hospital Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7999342980 |
| Fax |
|
| Email |
sivekgautam012345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHITRALEKHA THAKUR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ani Dullaiya Smriti Ayurved PG College and Hospital Bhopal |
| Address |
P.G. Department of panchakarma, OPD NO - 5, Rani Dullaiya Smriti Ayurved PG College and Hospital Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9424483133 |
| Fax |
|
| Email |
chitrathakur13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SIVEK GAUTAM |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College and Hospital Bhopal |
| Address |
P.G. Department of panchakarma, OPD NO - 5, Rani Dullaiya Smriti Ayurved PG College and Hospital Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7999342980 |
| Fax |
|
| Email |
sivekgautam012345@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sivek Gautam |
| Address |
PG Department of panchkarma OPD No.5 Rani Dullaiya Smruti Ayurved P.G. Mahavidyalay And Chikitsalay Bhadbhada Rd, Barkhedi Kala, Kopal, Bhopal, Madhya Pradesh 462044 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| SIVEK GAUTAM |
Rani Dullaiya Smruti Ayurved P.G.Mahavidyalay And Chikitsalay bhopal |
P.G.Department of panchkarma,opd No.5,rani duallaiya smriti ayurved P.G. mahavidhyalaya evam chikitsalaya, barkhedi kalan,Bhopal,M.P.
Bhopal
MADHYA PRADESH |
7999342980
sivekgautam012345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M242||Disorder of ligament. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: manjistha guggulu , Reference: vangsena samhita vatavyadhiadhikar 30/119, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 8(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: MANIJSTHA GUGGULU AVPIDAK NASYA IN AVBAHUKA
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: manjistha guggulu with erand nirgundi patra potli, Reference: vangsena samhita vatavyadhiadhikar 30/119, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 8(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: MANIJSTHA GUGGULU AVPIDAK NASYA & ERAND NIRGUNDI PATRA POTLI IN AVBAHUKA
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient having sign & symptom of avabahuka
both gender
age group 40 to 60 year
patient will be selected irrespective of caste, gender , socio economic background, habitat, occupation |
|
| ExclusionCriteria |
| Details |
patient below 40 years and above 60 years
pregnant women and lactating mothers.
known case of malignancy, hypertension, chronic renal failure, RTA,Gout, etc. |
|
|
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 |
| patient will get relief in symptoms of avabhauka |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient will get releif in associative symptoms of avabahuka |
30 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/01/2026 |
| 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="0"
Months="5"
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
|
THIS IS A DOUBLE GROUP , OPEN LABEL , COMPARARTIVE CLINICAL STUDY ON THE EFFICACY OF MANJISTHA GUGGULU AVPIDAK NASYA AND MANJISTHA GUGGULU ALONG WITH ERAND NIRGUNDI PATRA POTLI IN THE MANAGEMENT OF AVBAHUKA W.S.R. TO FROZEN SHOULDER . THE PRIMARY OUTCOME IS TO REDUCE PAIN AND STIFFNESS OF THE SHOULDER JONT WITH RELEIF IN ASSOCIATED FEATURES WILL BE MEASURED BY SUBJECTIVE AND OBJECTIVE CRITERIA. THIS TREATMENT PLAN CAN BE PROOVED TO BE EFFECTIVE IN TREATING ANSHASHOSHA. |