| CTRI Number |
CTRI/2026/02/103827 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study To Compare Ashwagandhadi Granules Alone and Ashwagandhadi Granules With Cupping Therapy In Neck Pain |
|
Scientific Title of Study
|
An Open Labelled Randomised Double Arm Clinical Study To Evaluate The Efficacy Of Ashwagandhadi Granules With and Without Cupping Therapy In The Management Of Manyastambh W.S.R. to Cervical Spondylosis |
| 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 Riddhi V Varan |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and research |
| Address |
Parul Institute of Ayurved and Research,Department of Kayachikitsa 3rd floor,Parul University,Ishwarpura, Limda,391760,Vadodara,Gujrat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
6354944278 |
| Fax |
|
| Email |
riddhivaran2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivangi choube |
| Designation |
Associate Professor and Guide |
| Affiliation |
Parul Institute of Ayurved and research |
| Address |
Parul Institute of Ayurved and Research,Department of Kayachikitsa 3rd floor,Parul University,Ishwarpura, Limda,391760,Vadodara,Gujrat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
9981411478 |
| Fax |
|
| Email |
drshivangi1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riddhi V Varan |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and research |
| Address |
Parul Institute of Ayurved and Research,Department of Kayachikitsa 3rd floor,Parul University,Ishwarpura, Limda,391760,Vadodara,Gujrat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
6354944278 |
| Fax |
|
| Email |
riddhivaran2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved and research Department of Kayachikitsa 3rd floor Parul University,Ishwarpura Limda,391760,vadodara,Gujrat,India. |
|
|
Primary Sponsor
|
| Name |
Dr.Riddhi V Varan |
| Address |
Parul Institute of Ayurved and research Department of Kayachikitsa 3rd floor Parul University,Ishwarpura Limda,391760,vadodara,Gujrat,India |
| 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 |
| Dr Riddhi V Varan |
khemdas hospital |
OPD NO.10 Ground Floor, Khemdas Hospital,Parul Institute Of Ayurveda And Research,Parul University,P.O Limda,Vadodara,Gujarat,India Pincode -391760
Vadodara
GUJARAT |
6354944278
riddhivaran2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE IEC-PIAR HR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Wet Cupping Therapy | (Procedure Reference: -, Procedure details: Preparation: Ensure treatment room is clean , well ventilated and adequately lit. Sterilised all cups and instruments. Prepare/ ensure that all tools are available in the cupping room . Use gloves and a sterile needle. Prepare the patient to lie down in prone position.
Site : Supra Scapular region and C7and T1 vertebra respectively.
Clean treatment area with antiseptic solution. if required ,apply thin layer of lubricant (organic honey)to improve cup sealing and minimize friction.
Procedure : Cup type: Plastic cup (one-time use )
22 no needle
sittings : 1 sitting in 15 days - 4 sitting in 2 months (if pain is reduced completely in 2 -3 sitting then sitting will be stopped.
Application: Identify the site. Disinfect site thoroughly.Apply cup over site for 5 min,vaccume created then remove it then prick with needle. Apply cup and draw blood. Maintain suction for 5 to 10 minutes. Monitor signs of discomfort or excessive bleeding.
Post procedure : Gently remove cups. Clean area with antiseptic soltion.Sterile gauze /dressing over the incised area. )
(1) Medicine Name: Ashwagandhadi Granules, Reference: Sahasrayoga, Route: Oral, Dosage Form: Khanda/Granules, Dose: 5(g), Frequency: bd, Duration: 2 Months | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ahwagandhadi Granules, Reference: Sahasrayoga, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: 20 patient will be enrolled in this group and granules will be given. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between ages of 18-60 years.
2.Patients having classical signs and symptoms of manyastambha. (cervical spondylosis) with or without radiological changes.
|
|
| ExclusionCriteria |
| Details |
1.Patient below the age of 18 and above age 60 years will be excluded in this study.
2.Known cases of trauma of neck, local wound and infection over neck, cervical rib syndrome, any spinal cord disorders other than cervical spondylosis , compress cord , canal stenosis. Known cases of shoulder and elbow musculoskeletal problems, fracture of spine and upper limb.
3.Patients with cervical spine diseases who are indicated for surgical intervention will be excluded from the study.
4.Severe anemia ( hb below 8) , bleeding disorders, hypotension.
5.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the efficacy of Ashwagandhadi Granules with and without Cupping Threapy On The Basis Of Subjective Parameters From Baseline To end of The Study.
2.To reduce the pain by VAS (1 to 10) 3.To Reduce pain By NDI |
Subjective Parameters:0,30,60th day
VAS :0,15,30,45,60th Day
NDI :0,30,60th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To Improve Range Of Motion by Goniometer.
2.To Iimprove quality of life by SF 36 Questionnaire . |
ROM : 0,15,30,45,60 th Day
QOL : 0,30,60th Day
|
|
|
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)
|
16/03/2026 |
| 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="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
|
This is an open-labelled, randomized, comparative double-arm interventional clinical study designed to evaluate the efficacy of Ashwagandhadi granules in the management of Manyastambha (Cervical Spondylosis), both with and without wet cupping therapy. A total of 40 patients aged 18–60 years fulfilling diagnostic criteria will be randomly divided into two groups: Group A will receive Ashwagandhadi granules (5 g BD with warm water after food) along with wet cupping therapy, and Group B will receive Ashwagandhadi granules alone for a duration of 60 days. Wet cupping will be performed in Group A at the suprascapular region and C7–T1 junction, with 1 sitting every 15 days (maximum 4 sittings). Patients will be followed up on the 15th, 30th, 45th, and 60th day. Assessment will be done using subjective parameters such as pain (Shoola), stiffness (Sandhigraha), headache, vertigo (Bhrama), tingling sensation, numbness, and tenderness (Sparshasahishnuta) with grading scales. Objective assessment parameters will include Visual Analogue Scale (VAS) for pain, Neck Disability Index (NDI) for functional disability, Range of Motion (ROM) of cervical spine measured by goniometer (flexion, extension, lateral flexion, and rotation), and Quality of Life (QOL) evaluation using the SF-36 questionnaire. Radiological screening will be performed using X-ray cervical spine lateral view. Laboratory investigations planned for patient safety include CBC, RBS, HBsAg, HIV, Bleeding Time (BT), and Clotting Time (CT) (BT and CT applicable specifically for cupping therapy patients). Safety monitoring will be ensured through adverse event recording, and rescue medication (Diclofenac sodium 75 mg SOS) will be provided if required. |