A Clinical trial on Komoothira Silasathu Chooranam in the management of Thandagavatham (Lumbar spondylosis) among patients attending OPD and IPD of Government Siddha Medical College and Hospital,Palayamkottai

A prospective open labelled single arm non- randomized single centric phase II clinical trial on Komoothira Silasathu Chooranam in the management of Thandagavatham (Lumbar spondylosis) - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068547

Enrollment

Registered

2024-06-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M478- Other spondylosis

Interventions

Intervention1: Komoothira Silasathu chooranam: DOSAGE:130 mgs twice a day orally for 48 days Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pain and stiffness in the lumbar region 2.Patient presenting with or without radiating pain to lower limb 3.Difficulty in range of motion 4.Patient who are willing to participate in the study

Exclusion criteria

Exclusion criteria: 1.Osteoarthritis of hip 2.Patient undergone spinal surgery 3.TB-Spine 4.SLE 5.Infection 6.Rheumatoid arthritis 7.Fracture of spine 8.Chronic renal and liver disease patients 9.Pregnancy and lactating mother

Design outcomes

Primary

Measure	Time frame
The outcome will be aimed at reducing the symptoms of Thandagavatham(Lumbar sponsylosis)and to determine the therapeutic efficacy of clinical trials drug(komoothira silasathu chooranam)Timepoint: 48 days	—

Secondary

Measure	Time frame
1.To collect various aspects of Thandagavatham in Siddha literatures. 2.To evaluate physico chemical,phyto chemical and bio chemical characters of Komoothira Silasathu chooranam. 3. To evaluate safety profile for assessing acute and sub-acute toxicity of trial drug Komoothira Silasathu chooranam. 4.To evaluate pharmacological analysis of Komoothira Silasathu chooranam. 5.To Study about the prevalence of Thandagavatham in relation between diet and life style. 6.To evaluate siddha parameters (including Envagai thervu) changes and dhegi of Thandagavatham patients during the study period. 7. To evaluate modern parametric changes in Thandagavatham patients 8.To document the Bio statistical analysis. 9. To assess the Quality of life of Thandagavatham patients.Timepoint: 6 months	—

Measure

Time frame

1.To collect various aspects of Thandagavatham in Siddha literatures. 2.To evaluate physico chemical,phyto chemical and bio chemical characters of Komoothira Silasathu chooranam. 3. To evaluate safety profile for assessing acute and sub-acute toxicity of trial drug Komoothira Silasathu chooranam. 4.To evaluate pharmacological analysis of Komoothira Silasathu chooranam. 5.To Study about the prevalence of Thandagavatham in relation between diet and life style. 6.To evaluate siddha parameters (including Envagai thervu) changes and dhegi of Thandagavatham patients during the study period. 7. To evaluate modern parametric changes in Thandagavatham patients 8.To document the Bio statistical analysis. 9. To assess the Quality of life of Thandagavatham patients.Timepoint: 6 months

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Countries

India

Contacts

Public ContactProf Dr T Komalavalli Alias Mehala

Government Siddha Medical College and Hospital, Palayamkottai

justusantony71@gmail.com9443090849

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026