| CTRI Number |
CTRI/2025/10/095660 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Trayodashanga Guggulu and Asanas on Sciatica Pain Relief. |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL EVALUATION OF THE EFFECT OF TRAYODASHANGA GUGGULU WITH/ WITHOUT SELECTIVE ASANAS IN THE PAIN MANAGEMENT OF GRIDHRASI W.S.R. TO SCIATICA. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitin |
| Designation |
Assistant Professor |
| Affiliation |
Motherhood Ayurveda Medical College & Hospital, Bhagwanpur, Roorkee |
| Address |
Motherhood Ayurveda Medical College & Hospital, Bhagwanpur, Roorkee
OPD no. 5, Dept of Swasthavritta, Motherhood Ayurveda Medical College & Hospital, Bhagwanpur, Roorkee
Hardwar
UTTARANCHAL
247661
India |
| Phone |
8077437338 |
| Fax |
|
| Email |
nitinkumar281987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Kulbhushan |
| Designation |
Professor & HOD Swasthavriotta Dept. |
| Affiliation |
OPD Swasthavritta, Desh Bhagat University, Amloh Road, Mandi Gobindgarh, Punjab |
| Address |
OPD Swasthavritta, Desh Bhagat University, Amloh Road, Mandi Gobindgarh, Punjab
Fatehgarh Sahib
PUNJAB
147203
India |
| Phone |
9465256484 |
| Fax |
|
| Email |
asinghay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Kulbhushan |
| Designation |
Professor & HOD Swasthavriotta Dept. |
| Affiliation |
OPD Swasthavritta, Desh Bhagat University, Amloh Road, Mandi Gobindgarh, Punjab |
| Address |
OPD Swasthavritta, Desh Bhagat University, Amloh Road, Mandi Gobindgarh, Punjab
Fatehgarh Sahib
PUNJAB
147203
India |
| Phone |
9465256484 |
| Fax |
|
| Email |
asinghay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Motherhood Ayurveda Medical College & Hospital, Bhagwanpur, Roorkee- 247661 |
|
|
Primary Sponsor
|
| Name |
Motherhood Ayurveda Medical College & Hospital, Bhagwanpur, Roorkee |
| Address |
Motherhood Ayurveda Medical College & Hospital, Bhagwanpur, Roorkee, Uttarakhand- 247661 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nitin |
Motherhood Ayurveda Medical College & Hospital, Bhagwanpur, Roorkee |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitin Kumar |
Motherhood Ayurveda Medical College & Hospital, Bhagwanpur, Roorkee |
OPD no. 5, Dept of Swasthavritta, Motherhood Ayurveda Medical College & Hospital, Bhagwanpur, Roorkee
Hardwar
UTTARANCHAL |
8077437338
nitinkumar281987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G50-G59||Nerve, nerve root and plexus disorders. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashang Guggulu, Reference: Bhaishajya Ratnavali, Vatavyadhi Chikitsa, 25, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: - Jala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | 1. Setu Bandhasana 2. Shishu Aasana | (Procedure Reference: Hatha Yoga Pradipika and Gheranda Samhita, Procedure details: Each Aasana 3-5mins.- empty stomach/ digestion of previous meal- morning & evening.
With medicine & only 01 asana (Shishu Aasana)- for 30 days.
With medicine & both asanas (Setu Bandhasana, Shishu Aasana)- for 30 days.)
(1) Medicine Name: Trayodashang Guggulu, Reference: Bhaishajya Ratnavali, Vatavyadhi Chikitsa, 25, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(mg), Frequency: bd, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient age between 20 to 60 years.
2. Patient irrespective of gender & religion.
3. Patient having cardinal feature ruja (pain)- mild to moderate of Gridhrasi not more than 01month.
4. Patient having radiating ruja (pain) to lower limb either unilateral or bilateral with any radiological changes.
5. Patients who are willing to give written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 20 years & above the age of 60 years.
2. Patients with any systemic/ chronic illness, any structural-anatomical deformities, pregnant & lactating women, Inter vertebral disc prolapse, spinal injuries, Infection of spine, congenital deformities etc.
3. Patient having cardinal feature ruja (pain) of Gridhrasi more than 01month.
4. Patients unfit for Yogasanas. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scoring pattern, as per severity adopted to assess the relief in symptom as follows – Ruja, SLR test. |
Assessment: Total 60 days (Follow-up in every 30 days).
Scoring pattern, as per severity adopted to assess the relief in symptom as follows – Ruja, SLR test. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Scoring pattern, as per severity adopted to assess the relief in symptom as follows – Ruja, SLR test. |
Assessment: Total 60 days (Follow-up in every 30 days). |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
22/10/2025 |
| 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="0"
Months="2"
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
|
Gridhrasi (sciatica) is a nanatmaja vata vyadhi marked by radiating pain from sphik to pada, with symptoms like stambha, ruk, toda, and spandana. Its prevalence (1.2–43%) is rising due to sedentary lifestyle, poor posture, and excessive labor.
Charaka describes it as radiating pain with stiffness, while Sushruta attributes it to kandara dushti by vitiated vata. Harita considers it due to vyana vata dushti. Modern science equates it with nerve compression causing sciatica.
Conventional therapies provide temporary relief with side effects. Trayodashanga Guggulu, a classical formulation for vatavyadhi, has analgesic and anti-inflammatory properties. Yogasanas strengthen the spine and reduce nerve compression. Though both show efficacy individually, comparative evidence is lacking. This study aims to evaluate their individual and combined effects, providing evidence-based integrative management for Gridhrasi. |