A Randomised Controlled Clinical Trial to evaluate the efficacy of Panchatikta Ghrita Guggulu over Lakshadi Guggulu after Panchaprasrta Basti in management of Asthishosha (Osteoporosis)

RESEARCH QUESTIONDoes the administration of Panchatikta Ghrita Guggulufollowed by Panchaprasrta Basti, when compared to Lakshadi Guggulu with the same pre-procedure, result in greater clinical improvement in patients between 31-60 years with Asthishosha (Osteoporosis)?HYPOTHESIS

There is difference in the efficacy of Panchatikta Ghrita Guggulu and Lakshadi Guggulu, when administered after *Panchaprasrta Basti,*in the management of Asthishosha (Osteoporosis)

NULL****HYPOTHESIS (H0)

There is no significant difference in the efficacy of Panchatikta Ghrita Guggulu and Lakshadi Guggulu, when administered after Panchaprasrta Basti, in the management of Asthishosha (Osteoporosis).

|ALTERNATE HYPOTHESIS(H1)

There is significant difference in the efficacy of Panchatikta Ghrita Guggulu and Lakshadi Guggulu, when administered after Panchaprasrta Basti, in the management of Asthishosha (Osteoporosis)

Inclusion criteria

Exclusion criteria

|Subjects aged between the age group of 31 and 60 years.

Patients on long-term medications such as steroids and antiepileptics drugs.

|Diagnosed case of Primary Osteoporosis by BMD Test (T  score of less than or equal to -2.5)

Osteomalacia, Rickets, Genetic causes, Juvenile Osteoporosis, Cushing syndrome, Marfan Syndrome,

|Lakshanas of   Asthishosha  Asthi Shoola,  Asthi Toda, Santat Ruka, Bhrama, Nakha Bhanga, Shrama, Raukshya, Aswapna.

Patient with uncontrolled diabetes mellitus, hypertension, thyroid and parathyroid disorders.

|Informed written consent

Patients fit for basti

Cancer Patients, Surgical Patients, Pregnant Women and Lactating mothers.

INVESTIGATIONS

INVESTIGATION

BEFORE TREATMENT

(0n 0th day)

AFTER TREATMENT

(0n 50th day)

|BMD

will be done

will be done

|VIT D, Serum calcium, CBC with ESR, Thyroid profile, Serum Parathyroid Hormone, KFT, LFT, Lipid Profile

 will be done

 will be done

EXPECTED OUTCOME MEASURES

Primary Outcome:

Changes in Bone Mineral Density (BMD) and Improvement in  lakshana of Asthishosha  Asthi Shoola,  Asthi Toda, Santat Ruka, Bhrama, Nakha Bhanga, Shrama, Raukshya, Aswapna.

Secondary Outcome:

Improvement in laboratory parameters VIT D, Serum calcium, CBC with ESR, Thyroid profile, Serum Parathyroid Hormone, KFT, LFT, Lipid Profile**.**

Improvement in quality of life related to osteoporosis using Quality of life scores with QUALEFFO 41 questionnaire developed by IOF.

METHODOLOGY

Parameter

Details

|Study Type

Comparative Interventional Clinical Trial

|Masking

Open label

|Interventional model

Parallel assignment

|Study Design

Randomized, open-label, comparative controlled clinical trial

|Sampling Frame (Selection of Cases)

OPD/IPD wing of AIIA according to diagnostic criteria

|Sampling Procedure

Probability

|Sample Size

54 (27 in each group)

|Number of Groups

2

|Timing

Prospective

|Intervention (Basti and Oral medications)

8 days and 6 Weeks

|Follow up

4 Weeks

|Review Period

Once in 2 weeks

DURATION OF STUDY

Basti administration period         8 days

Oral Medication Period              6 weeks

Follow Up Period                       4 Weeks

Review Period                          Once in 2 weeks

Sample SizeMinimum sample size is 27 in each group. Sample size will be increased as per feasibility or Stratified sampling and analysis will be considered .

GROUP A (Lakshadi Guggulu)  27

GROUP B (Panchatikta Ghrita Guggulu)  27