Effect of Pala Madakku Thailam (Internal Medicated Oil) on Osteoporosis

Not yet recruiting

Conditions: Other osteoporosis without currentpathological fracture,

Registration Number: CTRI/2022/07/044274

Lead Sponsor: National Institute of Siddha

Brief Summary: **Introduction:**

This is an open Non Randomised clinical trial thatevaluates therapeutic effectiveness of siddha formulation *Pala (Citramutti)Madakku Thailam* in the management of *Asthi vatham* (Osteoporosis)patients through improvement of T scores in Bone Mineral Densitometer Scanbefore and after treatment. Worldwide,it is estimated that 1 in 3 women above the age of 50 will experienceosteoporotic fractures, as well as 1 in 5 men. According to the Siddha, *Asthivatham* (Osteoporosis) can betreated using the trial drug. The major ingredient *Sida cordifolia* werefound to be effective in increasing the bone density in patients with osteoporosis in several studies. It also hasrich source of phytoestrogens which inhibit bone resorption and negate the boneresorption effects. Milk is an excellent calcium source and also suppresses thebone resorption in Osteoporosis. Sesamum indicum also exhibits pro-osteoblasticand anti-osteoclastic activity.

**Objective:** To evaluate the therapeutic effectiveness of *Pala(Citramutti) Madakku Thailam* in the management of *Asthivatham* (Osteoporosis) usingT scores of Bone Mineral Densitometer Scan before and after treatment.

**Materials and Methods**: An Open Non Randomised Clinical Trial witha total of 10 patients diagnosed of *Asthi vatham* (Osteoporosis) with ageof above 40 years willing to participate in the study ,by signing the informedconsent form will be enrolled in the study. The trial drug will be given for 90days along with 1 month follow up.

**Result**: The average T scores before and after treatment will be statisticallyanalysed.

**Keywords**: *PalaMadakku Thailam*, Osteoporosis

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Bone Mineral Density T-Score less than â€“ 1 will be included.

Exclusion Criteria

K/H/O Renal / Hepatic / cardiac disease 2.
K/H/O Prolonged glucocorticoid administration 3.
K/H/O Genetic or autoimmune disorders 4.
All cases of Secondary Osteoporosis including K/H/O Cushingâ€™s syndrome, K/H/O Hyperparathyroidism.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcome of the study will be assessed by using the	Screening - 2 months \| Enrolment - 2 months \| Intervention - 4 months \| Data Analysis - 2 months \| Follow up - 2 months
1. Bone Mineral Density Scan (Peripheral DXA Scan) T Score before and after treatment.	Screening - 2 months \| Enrolment - 2 months \| Intervention - 4 months \| Data Analysis - 2 months \| Follow up - 2 months
2. Improvement in Clinical symptoms before and after treatment.	Screening - 2 months \| Enrolment - 2 months \| Intervention - 4 months \| Data Analysis - 2 months \| Follow up - 2 months

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Ayothidoss Pandithar Hospital
🇮🇳
Kancheepuram, TAMIL NADU, India
Ayothidoss Pandithar Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Dr Thanigainathan A
Principal investigator
9489368257
atn1267@gmail.com